All posts by Turacoz Group

Regulations of Drug Approval in United States, European Union and Canada

Medical Devices,

Introduction

Drug regulations can be defined as the overall control of drug by following rules and regulations which are enforced by the government to protect the health and well-being of humans. They are crucial for ensuring high quality of the drug by confirming its efficacy, safety and quality. Every country has its own regulatory authorities such as the United States Food and Drug Administration (US-FDA for US), the European Medicines Agency (EMA for Europe) and Therapeutic Products Directorate (TPD for Canada which frame the regulatory requirements for development, approval, manufacturing and marketing of the drugs.

Regulations for Drug Approval in United States

USA is the main regulatory agency in the world and hence, it has the strictest standards for approving a new drug in US market. The regulator y authority of US, i.e., USFDA, is responsible for the safety regulation of the food and drug products in US. The drug approval process in US includes filing of Investigational New Drug (IND) application followed by New Drug Application (NDA).

Investigational New Drug Application

Once the drug is found to be safe, as per the reports of the preclinical trails, IND application (IND) is filed to the FDA to start the clinical trials or Phase I trial. The sponsor appointed by the firm or institution is responsible for submitting the IND application to the FDA for which a pre-IND meeting with FDA may be arranged in order to discuss the intended protocol for conducting the trial. The sponsor also provides information related to the chemistry, manufacturing details and quality control of the investigational drug.

New Drug Application (NDA)

After completion of all the clinical trials (i.e. Phase I, II and III trials), if the studies confirm the safety and effectiveness of the investigational drug, the manufacturer can file a New Drug Application (NDA) to the FDA for manufacturing and selling the drug in the US market.

Regulations for Drug Approval in Europe

The regulatory authority of the Europe, i.e., EMA, is responsible for the safety of the public in Europe. Prior to approval for marketing in EU, the applicant has to follow two regulatory steps mentioned below:

  • Clinical trial application
  • Marketing authorization application (MAA)

Clinical Trial Application

In Europe, the drug can be approved by four types of procedures depending upon the drug class and preference of the manufacturer. The four procedures are presented in Figure 1

Figure 1: Drug approval procedures followed in Europe

Marketing Authorization Application

The MAA is an application which is submitted by a drug manufacturer to the EMA in order to seek permission to market a developed drug product in Europe. MAA is approved at both, the state or centralized levels while the clinical trial application is approved at the state level only.

Regulations for Drug Approval in Canada

Therapeutic Products Directorate (TPD) is Health Canada’s federal authority which regulates the drugs and medical devices in Canada for human use. The applicant must present the scientific evidence on the product’s safety, effectiveness, and quality to the directorate in order to obtain permission to sell a drug product.

The Canada’s system of regulating a drug is quite similar to US. If an applicant wants to get marketing authorization in Canada then a new drug submission (NDS) must be compiled with clinical trial information and details of production, packaging, labelling, conditions for use and side effects must be submitted to TPD. Post-submission, it undergoes administrative screening to check the completeness of the document with appropriate format followed by review and assessment of safety, efficacy and quality. The TPD then evaluates the submission and communicates the deficiencies of the NDS to the sponsor to resolve them. After all the issues have been resolved, TPD issues a notice of compliance (NOC).

Turacoz Healthcare Solutions (THS) provides end-to-end regulatory writing support for clinical trials which includes Prescribing Information (PI), Investigator Brochures (IBs), Protocols, Clinical Study Reports (CSRs), Clinical Evaluation Reposts (CERs) and Common Technical Documents (CTDs).

Employee Empowerment

HR

Over and over we keep hearing about how employees want to feel connected to their work. How much they want their contributions to matter and impact the business as a whole. Empowering the team members is a great way to discover and develop the individual strengths, and then absorb them in new roles where they can excel.

Employee empowerment allows the employees to have control over their work. It gives a degree of autonomy and responsibility for decision-making in certain organizational tasks. Also, it encourages the employee to play a more active role in their work, involves them more in their specific role and enables them to make better, bigger and independent decisions (Figure-1).

Figure 1: Employee empowerment

 

In a corporate setting, employee empowerment can emerge out as powerful drivers for better performance, profitability and productivity for organizations (Figure-2).

Figure 2: Empowerment in corporate world

Turacoz Healthcare Solutions strongly believes in and practices employee empowerment. We take pride in providing employees with the skills, tools, information, and above all, the authority and responsibility for their work.

If you are looking to work with a team where every member is encouraged to be a performer, an achiever and a leader, come join us and be the part of our team!!! Share your profile on [email protected].

 

 

 

Challenges in Rare Disease Research: The Role of Advocacy Organizations in Overcoming these Challenges

Disease and Treatment, , ,

What is a Rare Disease

Rare disease refers to a condition that affects fewer people. The World Health Organization (W.H.O) has defined a rare disease as one with frequency less than 6.5-10 per 10,000 people. Challenges in Rare Diseases Research

Unlike the common disease, research in rare diseases encounters several challenges. They are:

  1. Recruiting, engaging, and retaining patients
  2. Designing and evaluating clinical trials
  3. Lack of funding

It is important to overcome these challenges to develop treatment for rare diseases and provide the affected patients a better quality of life. A boost in the research of rare disease has occurred in last two decades, the credit for this can partly be given to the patient advocacy groups.

Patient Advocacy Groups

Patients advocacy groups (PAGs) refer to the organizations, mostly non-profit, that are often concerned with one specific group of disorders. The history of the development of PAGs for specific disease dates to mid-1930s. Initially, the PAGs role was to provide emotional and social support to the affected patients; however, later they also started initiating and conducting research. As per the estimates, there are more than 1200 patient organizations in the U.S. alone that advocate patients with one or more rare diseases.

PAGs help patients with rare diseases in various ways as listed below:

  • They help patients seeking information on therapeutic options, the latest research, or financial aid resources.
  • They encourage research on the disorder by enrolling patients in studies and being involved in the study design. They may also help to look for volunteers and control subjects, to collect data, and analyze it.
  • They are involved in developing and updating guidelines related to disorders.
  • They provide emotional support to the affected individuals by organizing social events where they can meet other individuals affected with the same disorder.
  • They are involved in initiating and conducting research for new therapies, natural history information, management and care for their disorder.
  • They are involved in creating a registry of individuals affected with a rare disorder or a biobank of specimens.

Thus, the PAGs can help overcome the above-mentioned challenges associated with rare disease research.

A single organization is usually involved in one (or may be 2 to 3) of the above activity. The table below enlists some rare disease organizations that initiated research either with staff scientists of the advocacy groups or in partnerships with scientists from academic institutions or industry (Table 1).

Table 1: Advocacy Organizations and Their Achievements

 

These PAGs are linked to one or more bigger networks. Let us discuss one such bigger network.

Rare Diseases Clinical Research Network and Patient Advocacy Groups

The Rare Diseases Clinical Research Network (RDCRN) group was formed in 2003 by the Office of Rare Diseases Research (ORDR) National Center for Advancing Translational Sciences (NCATS).in collaboration with six other Institutes and Centers (ICs). It funded 10 Rare Diseases Clinical Research Consortia (RDCRC) and a single Data Management and Coordinating Center (DMCC) for the whole Network. Following its expansion in 2014, RDCRN collaborated with ten Institutes and Centers of the National Institute of Health and include 22 consortia and one DMCC. It was announced that these consortiums will collaborate with 98 PAGs as research partners. A recent study by Merkel et al (2016) outlines the roles patients and PAGs play in the RDCRN and reports on the PAGs’ impact on the Network’s success. The activities of PAGs are presented in Figure 1.

RDCRN: Rare Diseases Clinical Research Network; PAG: Patient advocacy group

Figure 1: Activities of patient advocacy groups

Thus, PAGs form a pillar in conducting rare disease research. They can help reach the treatment to millions of individuals with rare diseases worldwide. Turacoz Healthcare Solutions aims to spread awareness about the role of patient advocacy groups in the rare disease research.

Rare Disease Day: Raising Awareness towards Rare Diseases and Orphan Drugs

Awareness Day/Month

Rare Disease Day

On the 28th of February, rare disease day is celebrated globally every year. This day was established for the first time by EURORDIS (The European Rare Disease Organization) in 2008 to spread awareness amongst the public about rare diseases and their impact on the lives of patients suffering with them. Further, it sought to raise awareness about the challenges faced by these patients, their unmet needs and the importance of research and development in the field. In 2009, NORD [The National Organization for Rare Disorders, United States (US)] supported the initiative by EURORDIS and Rare Disease Day was sponsored in the US by both the organizations in partnership. The concept was then propagated beyond Europe and US to spread awareness around the world.

Rare/ Orphan Diseases

Rare diseases also called as orphan diseases affect small number of patients. These diseases might cause serious and life threatening or fatal consequences. The designation of disease as rare/ orphan differs from country to country. As per World Health Organization (WHO), a disease affecting 6.5-10 individuals for every 10,000 people is referred to as rare/orphan disease. However, as per European Union (EU), the diseases with prevalence of 5 per 10,000 people are considered as orphan. While, USA designates a disease as rare if it has an incidence lesser than 7.5 individuals per 10,000 of population. As a clear definition of rare diseases in Indian context was not defined, a non-profit organization namely Organization for Rare Diseases in India (ORDI) took the initiative to define them. According to ORDI, a disease with a prevalence of ≤1 per 5000 people may be referred to as a rare/orphan disease. The estimated prevalence of rare diseases in South Asian countries according to Foundation for research on Rare Diseases and Disorders (FRRDD) is given in Table-1.

Table:1 Prevalence of rare diseases in South Asian countries

 

Challenges Related to Rare Diseases

There are numerous challenges that pertaining to rare diseases. These are as follows:

  • Lack of general understanding about the underlying mechanism responsible for these diseases.
  • Difficulty in recruitment of clinical trials and experimental studies owing to the rarity of diseases and their widely dispersed prevalence.
  • Centers for their diagnosis and treatment are scarce.
  • Research and development is this field is also highly neglected.

Orphan Drugs

Orphan drugs are those that are used for the treatment of an orphan disease. Apart from disease rarity, other concepts also underlie the designation of a drug as orphan. Certain drugs are assigned as orphan based upon their feasibility and financial profits. Illustrating this, few vaccines and drugs which are employed to manage tropical diseases are categorized as orphan drugs. This is attributed to the fact that financial benefits to the drug developers is minimal. The population suffering from these diseases is often incapable to bear their cost and thus they must be provided at a subsidized rate thereby, giving minimal financial benefits to drug developers.

In addition, the drug is also categorized as orphan if it might have earlier been withdrawn from the market and later revives back afresh with recognition of its role in treating some other affliction. For instance, thalidomide, which was once withdrawn from market due to the landmark tragedy in mid-1960s has revived back in recent years is an orphan drug to treat lupus erythematosus.

The recent paradigm shift in market trends and profitability in research and development of orphan drugs and related regulation shall be discussed in our upcoming blog.

Turacoz Healthcare Solutions understands its responsibility towards society and this blog is an initiative to draw attention of healthcare providers and pharmaceutical companies towards the unaddressed needs of patients with rare diseases.

Practicalities of Working From Home

HR

Work-From-Home (WFH) is one of the main argument topics lately. WFH as well as flexible working hours are the two major retention tools for working mothers and even other employees. Time is changing very fast, and it has become necessary to build a transparent culture within, which includes trusting employees to work whenever they want. The benefits of working from home are shown in Figure-1.

 

Figure-1: Practicalities of Working from Home

 

We @Turacoz Healthcare Solutions understand the significance of a better work-life balance and realize that employees often value the flexibility of working from home. We firmly believe that best work does not always happen within the restricted office hours of 9-5 and hence have integrated remote working arrangements and flexi time in our culture. So, if you are interested in what we do and looking for a gig that will let you work from home completely/occasionally, reach out to us at [email protected] . To know more about our company visit https://turacoz.com/ and http://www.turacozskilldevelopment.org/.

Regulations of Medical Devices in India: An Update

Medical Devices

Medical devices comprise of a vast range of equipment, ranging from a single pair of tongs to a heart-lung machine. Along with medicines and allied healthcare technologies, medical devices are important for modern patient‑centric care in all sorts of clinical settings like bedside, rural clinics, or metro hospitals. Medical devices have improved the quality of healthcare by making diagnosis, prevention, treatment, and monitoring of diseases simpler and efficient.

Indian medical device industry

Medical device industry is a huge industry, manufacturing wide range of products. In India, the medical device industry has a relatively small share of the global market when it is compared to the size of its economy. India ranks twentieth in the world in medical device market and it is fourth largest market in Asia. Most of the medical devices are imported in India which constitutes over 65% of the total market. The Indian medical device industry is driven by foreign manufacturers. The largest medical device manufacturing segment (53.7%) in India comprises of medical electronics, hospital equipments, and surgical apparatus. Around 31.3% of the medical device industry deals with medical disposables and consumables while diagnostic reagents and implants contributes to 7.9% and 7.1% of the market share respectively (Figure 1).

 

Figure 1*: Components of Indian Medical Devices Industry

*Source: Sethi R, Popli H, Sethi S. Medical Devices Regulation in United States of America, European Union and India: A Comparative Study. Pharm Regul Aff. 2017;6(1):1-9.

Medical devices regulations in India (CLAA scheme)

The Central Drug Standard Control Organization (CDSCO) has assigned a particular division i.e. Medical Device and Diagnostics Division which is dedicated to regulate the medical devices. Under the Central Licensing Approval Authority (CLAA) scheme, the CDSCO notified some of the medical devices and diagnostic kits which are being regulated for the manufacture, import and sale of the medical devices. These medical devices are also called as notified devices. The medical devices are regulated by Drugs and Cosmetics Act (1940) and Rules (1945) for the purpose of import, manufacture, sales and distribution. Currently, fourteen medical devices are notified under the CLAA scheme which are mentioned below:

  1. Disposable Hypodermic Syringes
  2. Disposable Hypodermic Needles
  3. Disposable Perfusion Sets
  4. In-vitro Diagnostic Devices for HIV, HBsAg and HCV
  5. Cardiac Stents
  6. Drug Eluting Stents
  7. Catheters
  8. Intra Ocular Lenses
  9. V. Cannulae
  10. Bone Cement
  11. Heart Valves
  12. Scalp Vein Set
  13. Orthopaedic Implants
  14. Internal Prosthetic Replacements

Current medical device rules (2017) in India

The Government of India has realized the need for framing separate rules and regulations for medical devices in order to improve the Indian regulatory system for medical devices. Hence, Government of India has issued a draft of medical devices to help the medical device industry and will separate the regulatory norms for manufacturing of medical devices from drugs. The draft of medical device was issued on January 31, 2017 and came into force on January 31, 2018.

The new rules and regulations for medical devices will create a novel and different regulatory apparatus by creating a separate registration process for medical devices. The key features of medical device rules, 2017, are summarized below:

  • The new rules have classified the medical devices on the basis of risk. These classes include:
  • Class A – Low risk

(e.g. catheters, surgical dressings)

  • Class B – Low moderate risk

(e.g. disposable hypodermic needles, orthopedic implants)

  • Class C – Moderate high risk

(e.g. cardiac stents, internal prosthetics replacements)

  • Class D – High risk

(e.g. drug eluting stents, heart valves)

  • The Indian regulators will have unique identification for their devices.
  • The medical devices should follow the standards established by the Bureau of Indian Standards (BIS). Where no relevant standard of any medical device has been laid down, then those devices should follow the standards laid down by International Organization for Standardization (ISO) and International Electrotechnical Commission (IEC) standards.
  • Licenses will remain valid indefinitely which are issued to the device registrants, along with the payment of the license retention fees, unless cancelled or surrendered.
  • Licenses and registration certificates received before the implementation of the new rules will be valid till expiry or after an 18-month period following implementation, whichever is later.
  • Test license will be valid only for one year.
  • The manufacturing sites of the devices will be audited by the notified bodies.
  • Medical devices for which trials are not required will need only a pilot study on a smaller population in order to test the safety and performance of the device followed by a pivotal trial on a large population.
  • These rules would be imposed by Central Licensing Authority and State Licensing Authority
  • The Central Licensing Authority is responsible for importing medical devices of all classes, and manufacturing of class C and D medical devices. Also, it is responsible for clinical investigation and approval of investigation of devices, and co-ordination with the State Licensing Authorities.
  • The State Licensing Authorities are responsible for the manufacturing, sale, and distribution of the devices that fall under class A or B, and also, control of sale, stock, exhibit, or offer for sale or distribution of in-vitro medical devices (IVDs) of all classes.

The new rules for medical devices will improve the accessibility and affordability of medical devices globally and will create a favourable and encouraging environment for development and innovation of new medical devices in India. The main objective of Government of India, through these rules, is to develop the confidence of the investors in medical device industry in India and to maintain the quality of all devices as per the international standards.

Turacoz Healthcare Solutions (THS) always aims to keep professionals updated on the current rules and regulations pertinent to regulatory affairs. Turacoz is dedicated towards providing scientific/medical writing support to the industry and academia. With expertise in various clinical trial related documents like Investigator Brochures (IBs), Protocols, Clinical Study Reports (CSRs), Common Technical Document (CTD), and Prescribing Information (PI), we aim to deliver the best quality and guideline compliant documents to the pharma and different sectors of healthcare industry.

Clinical Evaluation Report for Medical Devices-Role of Medical Writer

Medical Devices

Clinical Evaluation Report for Medical Devices

Clinical evaluation report (CER) is a document containing information regarding clinical evaluation of a medical device. CER is intended to be reviewed by the Notified Body (NB). Clinical evaluation refers to an organized procedure (Figure 1) used to collate, compile, and analyze clinical data related to a medical device. The clinical data includes updated published information on a medical condition and the medical device which is obtained from various databases. It also includes pre-clinical and clinical data, quality control data, and risk management and post-market surveillance related inputs which are obtained from manufacturers, quality and safety scientists, respectively. The clinical information also includes the instructions to be followed while using the medical device. The CER is prepared as per the guidelines mentioned in MEDDEV 2.7/1 Rev. 4 (June 2016). It specifies the structure as well as content to be added in the CER.

 

Figure 1: Organized procedure followed for Clinical Evaluation of a Medical Device

(Reference: MEDDEV 2.7/1 Rev. 4, June 2016, Section 6.3)

 

MEDDEV 2.7/1 Rev. 4 (June 2016)

MEDDEV 2.7/1 Rev. 4 (June 2016) is the guideline followed to prepare the CER. It includes summary of CER, updated published information about medical condition for which the medical device is used, as well as complete information about device under evaluation (Figure 2).

Figure 2: Table of content for development of Clinical Evaluation Report

(Reference: MEDDEV 2.7/1 Rev. 4, June 2016, Section 6.3)

Role of Medical Writer in the Development of Clinical Evaluation Reports

Medical writer plays an essential role in development of CERs. According to the requirements of MEDDEV 2.7/1 Rev. 4 (June 2016), the medical writer performs various activities (Figure 3).

Figure 3: Role of a medical Writer in development of Clinical Evaluation Report

Turacoz Healthcare Solutions, a medical communication company, provides latest updates on medical devices. Turacoz is dedicated in providing scientific/medical writing support to the industry and academia. With expertise in several clinical trial related documents such as Investigator Brochures (IBs), Protocols, Clinical Study Reports (CSRs) and Common Technical Documents (CTDs), Prescribing Information (PI), we aim to deliver the best quality and guideline compliant documents to the Pharma and different sectors of Healthcare Industry.

 

Recent Advancements in Cancer Diagnostics

Cancer

Global Cancer Diagnostics Market

The global cancer diagnostics market was estimated to be USD 16.55 billion in year 2016. It is expected to reach USD 232.7 billion by 2025 as per a new report released by Grand View Research, Inc. This boost in the cancer diagnostics market is majorly attributed to the advances in diagnostic technology. Although the newly developed diagnostic modalities remain costly, but they provide an incremental benefit.

Recently Developed Cancer Diagnostic Methods

  1. Magnetite Nanoparticles (MNPs)

Iron oxide, owing to their higher biocompatibility and least toxicity, is the only metal oxide nanoparticle that is approved for clinical use. These nanoparticles are used for diagnostic imaging to enhance image contrast as they accumulate selectively at tumour sites and thereby, provide precise details about tumour. Besides diagnostics, MNPs, when loaded with therapeutic agents such as daunorubicin, are used for the treatment of various cancers such as blood cancer, prostate cancer, etc. Their properties have also been harnessed to induce localized magnetic hyperthermia for cancer treatment.

With the recognition of MNP’s potential for theranostics (diagnostics + therapeutics), further researches are ongoing to develop new techniques for localization of non-palpable breast lesions and its applications in therapy for breast cancer and other tumours.

  1. Biosensors

Biosensor is a diagnostic device used to detect a biological analyte, i.e. tumour biomarkers (certain molecules/ proteins expressed and/or secreted by tumour cells). Biosensor rapidly analyses and measures the cancer biomarkers present and thereby helps in detection of cancer and its nature benign/malignant). In addition to diagnosis, biosensors also help in monitoring the efficacy of anticancer agents. They provide instant information to the treating physician at office (point of care) which greatly influence treatment planning and patient management. Their use is extended to diagnose wide range of cancers including lung cancer, oral cancer, breast cancer and many more.

A biosensor device is formed by three components, namely recognition component (detects signal), signal transducer (responsible for conversion of biological signal to electrical output), and processor (displays result). These are simple tool having huge potential for sensitive and specific detection of cancer biomarkers. Most of the currently available biosensors utilize single biomarker for detection of cancers. However, cancers usually express multiple biomarkers. Therefore, there is a need to develop biosensors with improved diagnostic accuracy and repeatability that can perform multiple analysis.

  1. Next-Generation Sequencing (NGS)

The advent of NGS technology have revolutionized the cancer diagnostics. In contrast to traditional DNA sequencing methods, simultaneous sequencing of numerous DNA fragments can be performed using NGS technique even without any prior knowledge about DNA sequences. This technique allows sequencing of complete genome within few days at a cost less than $1000/genome.

Presently, NGS technique is available in two types, namely short read sequencing and long read sequencing. The short-read technique is relatively cheaper and can read sequences that are less than 300 base pairs. The contrast long-read technique is costly and allows reading of sequences larger than 2.5 Kilo bases.

Cancer diagnostics is an evolving field and numerous researches are always underway to develop more advanced modalities. Turacoz Healthcare Solutions aims to keep everyone updated on the newer technologies and help spread awareness on the current and upcoming trends.

Chimeric Antigen Receptor (CAR) T-cell Therapy: An Emerging Therapy for Cancer

Cancer,

Cancer is the second most common cause of death after heart disease. The treatment of cancer depends upon the type of cancer and at what stage it is being diagnosed. Due to low socioeconomic status and low literacy rate, patients often opt traditional methods and alternative medicines instead of seeking proper treatment. There are numerous methods such as surgery, radiation therapy, chemotherapy, stem cell transplant, etc., which are being used for the treatment of cancer. However, the major concerns associated with these therapies are their adverse effects and the recurrence of the disease. Nowadays, immunotherapy is budding as a promising method for the treatment of cancer as it is associated with minimal adverse effects and low risk of disease recurrence.

The emergence of immunotherapy, i.e., using body’s own immune system, to fight with cancer has been seen from the past two decades. William B. Coley, father of immunotherapy, was the first person to use immune system to treat cancer in the late 19th century. Recently, researchers have developed and approved a new Chimeric Antigen receptor (CAR) T- cell therapy for the treatment of cancer.

CAR T-cell Therapy: A Promising Therapy to Fight Cancer

CAR T-cell is a new therapy that has shown favorable result in the treatment of the cancer. This therapy uses T-cells from the patient’s cell which are further modified to target cancer cells. The therapy is a type of cellular therapy which functions by using body’s own immune system to destroy cancer cells.

Since the treatment involves extraction of T-cells from the blood, the patients may face the risk of infection and may temporarily have low blood cell counts and need transfusion support.

CAR T-cell Therapy: Updated Status

CAR T-cell therapy has been found to be effective in the treatment of cancer and also received approval from Food and Drug Administration (FDA) for cancer treatment. Novartis was the first ever company to receive the United States (US) FDA approval for CAR T-cell (Kymriah (TM) (CTL019)) therapy in August 2017 after years of research and clinical trials. Kymriah is the first gene therapy that is approved for the pediatric and young adult patients with a form of acute lymphoblastic leukemia (ALL).

Kite’s Yescarta (Axicabtagene Ciloleucel) is the second most CAR T-cell therapy which got FDA approval in October 2017 to treat adults with certain types of large B-cell lymphoma. Yescarta is the first approved therapy for certain types of non-Hodgkin lymphoma (NHL).

An ongoing phase I clinical trial (NCT00968760) is focusing on the use of gene transfer in patients with advanced B-cell lymphoma. Another interventional clinical trial, in phase I (NCT02186860), aims to determine safety and effectiveness of third generation CART-cells in patients with refractory acute lymphoblastic leukemia. The results of both the clinical trials are awaited.

CAR T-cell therapy: Pharmaceutical development

Several companies such as Novartis, Bluebird bio, Kite Pharma and Juno therapeutics are in lead to develop CAR T-cell therapy. Recently, Gilead and Kite Pharma associated with Pfizer to work on a combination of Yescarta-Utomilumab, which could be beneficial in treating certain blood cancers.

CAR T-cell therapy is one of the recent advancements in the field of cancer immunotherapy and Turacoz Healthcare Solutions (THS) aims to keep professionals updated on the recent advancement in cancer therapeutics and patient care. Turacoz is dedicated in providing scientific/medical writing support to the industry and academia. With expertise in several clinical trial related documents such as Investigator Brochures (IBs), Protocols, Clinical Study Reports (CSRs) and Common Technical Documents (CTDs), Prescribing Information (PI), we aim to deliver the best quality and guideline compliant documents to the Pharma and different sectors of healthcare Industry.

Why is Healthcare Regulation so Complex?

Regulatory Writing

Healthcare systems are driven by regulations which ensure patient’s access to safe, effective, and high-quality products. Regulations are basically rules which are framed by the government or the regulatory authority of the respective region so that risk associated with public health is under scanner. Regulations help in improving the quality and affordability of healthcare. These regulations are implemented by all levels of government including federal, state, local, and private organizations. However, many a times there is lack of coordination between them which results in complexity of the healthcare regulations.

What Makes Regulation Complex?
Healthcare sector is currently the largest and fastest growing industry which is making the regulations more diverse and complex to provide safe and quality service to every individual who accesses the healthcare system. The reason behind complexity of healthcare regulation is a series of historical tragedies like thalidomide and sulfanilamide tragedy. Thalidomide tragedy took place in early 1960s where the drug was prescribed as sedative and later was used for nausea in pregnant women. The drug got marketed in Germany without passing rigorous drug approval and monitoring system. This led to the birth of infants with phocomelia (congenital deformity which leads to development of abnormally short limbs). Similarly, sulfanilamide disaster took place in 1937, where the drug which was used for Streptococcal infections was responsible for deaths of more than 100 people in 15 states. These incidences later gave a lesson to drug safety and regulatory authorities leading the regulatory bodies to structure strict rules and regulations.

What is the Role of Healthcare Regulatory Bodies?
The pharmaceutical industry is considered as one of the most highly regulated industries worldwide where the regulatory bodies are responsible to enforce rules and regulations and issue guidelines for regulating drug development process, manufacturing, and marketing of any given pharmaceutical product. The European Medicines Agency (EMA) of Europe, Ministry of Health, Labour & Welfare (MHLW) of Japan, and Food and Drug Administration (FDA) of the United States came together for scientific and technical discussion and make some common standards on quality, safety, and efficacy of pharmaceutical products by the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The main aim of ICH is to harmonize technical regulatory standards in different countries in order to avoid duplicative testing in pharmaceutical development.
In conclusion, healthcare sector has flourished over the past hundred years irrespective of the complicated nature of healthcare regulations which has shown that the complexity has served to support and nurture the overall enterprise. However, regulatory bodies keep changing their laws constantly for betterment of the public health.
Turacoz healthcare solutions (THS) aims you keep you updated about the recent trends related to healthcare regulations and guide you through the fine technicalities of the same. We provide end-to-end regulatory writing support for clinical trials which includes Investigator Brochures (IBs), Protocols, Clinical Study Reports (CSRs) and Common Technical Documents (CTDs).