Pharma: Regulatory Affairs | Regulatory Landscape | UAE | الشؤون التنظيمية للأدوية في دولة الإمارات العربية المتحدة

Pharmaceutical regulatory affairs is a field that involves the process of obtaining and maintaining the necessary regulatory approvals for the development, manufacture, and marketing of pharmaceutical products. Regulatory affairs professionals are responsible for ensuring that pharmaceutical products meet the necessary regulatory standards and requirements in order to be safely and effectively used by the public.

The pharmaceutical industry is a vital sector in the United Arab Emirates (UAE), with a strong focus on innovation and research and development. The UAE has a well-established regulatory framework in place to ensure the safety and quality of pharmaceutical products, with several regulatory agencies and bodies responsible for overseeing the industry. These include the Ministry of Health and Prevention, the Ministry of Climate Change and Environment, and the Dubai Health Authority, among others.

The pharmaceutical industry in the UAE is supported by a number of initiatives and programs aimed at promoting research and development, such as the Sheikh Khalifa Excellence Award and the Dubai Biotechnology and Research Park. The UAE is also home to several major pharmaceutical companies and research institutions, making it an attractive location for regulatory affairs professionals to work and advance their careers.

The role of regulatory affairs in the pharmaceutical industry

Key responsibilities of regulatory affairs professionals in the pharmaceutical industry

The role of regulatory affairs in the pharmaceutical industry is critical in ensuring the safety, efficacy, and quality of pharmaceutical products. Regulatory affairs professionals are responsible for managing the process of obtaining and maintaining the necessary regulatory approvals for the development, manufacture, and marketing of pharmaceutical products.

Some key responsibilities of regulatory affairs professionals in the pharmaceutical industry include:

Reviewing and preparing regulatory submissions for new products, including clinical trial applications, marketing authorization applications, and post-approval changes

Ensuring compliance with all relevant regulatory requirements, including those related to good manufacturing practices (GMP), good clinical practices (GCP), and good laboratory practices (GLP)

Maintaining up-to-date knowledge of relevant regulatory guidelines and requirements, and providing guidance to internal stakeholders on how to comply with these guidelines

Liaising with regulatory agencies and bodies to ensure that regulatory submissions are processed in a timely and efficient manner

Providing support to the marketing and sales teams in the development of promotional materials that meet regulatory requirements.

By performing these and other tasks, regulatory affairs professionals help to ensure that pharmaceutical products are safe, effective, and of high quality, which is essential for protecting the public's health.

The regulatory framework for the pharmaceutical industry in the UAE

The pharmaceutical industry in the United Arab Emirates (UAE) is regulated by a number of agencies and bodies at the federal and local levels. These regulatory agencies and bodies are responsible for overseeing the development, manufacture, and marketing of pharmaceutical products to ensure their safety, efficacy, and quality.

Some of the key regulatory agencies and bodies responsible for the pharmaceutical industry in the UAE include:

Ministry of Health and Prevention: This agency is responsible for regulating the pharmaceutical industry at the federal level, including setting guidelines and standards for the import, manufacture, and distribution of pharmaceutical products.

Ministry of Climate Change and Environment: This agency is responsible for regulating the environmental impact of the pharmaceutical industry, including the management of hazardous and waste materials.

Dubai Health Authority: This authority is responsible for regulating the healthcare sector in the emirate of Dubai, including the pharmaceutical industry.

There are several key regulations and guidelines that govern the pharmaceutical industry in the UAE, including:

Federal Law No. 4 of 1983 Concerning Pharmaceutical Products: This law sets out the regulatory framework for the pharmaceutical industry in the UAE, including requirements for the registration, import, manufacture, and distribution of pharmaceutical products.

Federal Law No. 13 of 2013 Concerning Clinical Trials: This law sets out the regulatory framework for conducting clinical trials in the UAE, including requirements for the approval, conduct, and reporting of clinical trials.

UAE Good Manufacturing Practices (GMP) Guidelines: These guidelines set out the requirements for the manufacture of pharmaceutical products in the UAE, including requirements.

Challenges and opportunities for regulatory affairs professionals in the UAE

Like any other field, the pharmaceutical regulatory affairs industry in the United Arab Emirates (UAE) has its own set of challenges and opportunities. Regulatory affairs professionals in the UAE may face a range of challenges, including:

Keeping up with constantly evolving regulatory requirements: The pharmaceutical industry is subject to a constantly changing regulatory landscape, and regulatory affairs professionals must stay up to date with the latest guidelines and requirements in order to ensure compliance.

Managing multiple regulatory agencies and bodies: The UAE has a number of regulatory agencies and bodies that are responsible for overseeing the pharmaceutical industry, and regulatory affairs professionals must navigate this complex landscape in order to obtain the necessary regulatory approvals.

Ensuring compliance with international regulations: The UAE is a hub for the pharmaceutical industry in the Middle East, and many pharmaceutical products are exported to other countries. Regulatory affairs professionals must ensure compliance with the regulatory requirements of these countries in order to secure marketing approvals.

Despite these challenges, there are also many opportunities for growth and advancement in the pharmaceutical regulatory affairs industry in the UAE. The UAE is home to several major pharmaceutical companies and research institutions, and regulatory affairs professionals can take advantage of these opportunities to advance their careers and build their expertise. Additionally, the UAE is a hub for the pharmaceutical industry in the Middle East, and regulatory affairs professionals can take advantage of this to work on a wide range of projects and products.

Pharmaceutical regulatory affairs is a vital field that plays a critical role in ensuring the safety, efficacy, and quality of pharmaceutical products in the United Arab Emirates (UAE). Regulatory affairs professionals in the UAE are responsible for managing the process of obtaining and maintaining the necessary regulatory approvals for the development, manufacture, and marketing of pharmaceutical products.

The UAE has a well-established regulatory framework in place to oversee the pharmaceutical industry, with several regulatory agencies and bodies responsible for ensuring compliance with relevant regulations and guidelines. Despite the challenges that regulatory affairs professionals may face, there are also many opportunities for growth and advancement in the pharmaceutical industry in the UAE.

Looking to the future, the outlook for regulatory affairs professionals in the UAE is positive. The pharmaceutical industry in the UAE is expected to continue to grow and innovate, with a focus on research and development. This will create ongoing demand for skilled regulatory affairs professionals who can help to ensure the safety, efficacy, and quality of pharmaceutical products in the UAE and beyond.

FDA: Oncology Drugs | Approval | Criteria | معايير الموافقة على أدوية الأورام في إدارة الغذاء والدواء الأمريكية

OncoHealth, the main advanced health association zeroed in on the physical, internal and financial complications of complaint care, has delivered its Q2 2021 daily report on the FDA's lately approved specifics and motes and featured the progressed with lift in sped up blessings just as new worries around their development.

OncoHealth's daily report also uncovers that 29 of signatures contained a safe designated spot asset and 43 were biomarker inferior.

50(seven of 14) of new oncology signs got sped up blessings in the quarter up from 36 from an analogous quarter in 2020.

Charges for the specifics getting sped up blessings in Q2 2021 went from$,404 to$,336 yearly. in the beyond two times, the FDA has allowed 38 sped up blessings in oncology specifics.

" As the FDA inclines up sped up blessings, large figures of the new motes are being conceded with aware positive thinking," said, Senior Vice President, Pharmacy at OncoHealth." Detainments in conformational primary issues and absence of quick exertion by the FDA when preceding examinations sizzle has driven some to address whether the FDA has permitted their evidence principles to turn out to be exorbitantly tolerant and disagreeing."

In fresh examination of FDA blessing action in Q2, the report takes note of that notwithstanding the attention on the COVID- 19 epidemic in the course of recent months, the FDA was as yet bustling supporting oncology- related drug motes. The 14 blessings in the quarter gets the absolute the primary portion of 2021 to 34 supported oncology motes. That's notwithstanding the 66 oncology related blessings in 2020.

OncoHealth's Q2 2021 report also noticed that insusceptible designated spot impediments keep on growing being used, setting their place as standard of care in further than 17 distinctive growth types and two growth rationalist motes basically working on the results of malice cases.

Right around a third (29) of new oncology motes during the alternate quarter of 2021 involved an insusceptible designated spot asset, over from 25 during an analogous quarter of 2020.

A dependable subject has arisen around one of every four FDA blessings contains a safe designated spot asset. New delicacy drug blessings also kept on developing. In Q2 2021, 43 of approved oncology motes were biomarker inferior. Two of the seven new infinitesimal rudiments (NMEs), or candescent new to show oncology medicines supported in the alternate quarter of 2021 flashed back new sub-atomic focuses for cutting edge/ metastatic non-little cell cellular breakdown in the lungs (NSCLC).

" Oncologists are precipitously going to germline and physical cancer testing to all the more probably educate remedy

FDA: Accelerated Approval | Process | New Drugs | عملية الموافقة المعجلة لإدارة الغذاء والدواء على الأدوية الجديدة

 

The FDA has an accelerated approval mechanism for new drugs. Is accelerated FDA approval a good thing? Probably Yes. This mechanism of approval was put into place to help patients who suffer from certain serious diseases.

As the phrase suggests accelerated FDA approval involves a faster approval than for non-accelerated approvals. To get an accelerated approval sponsors must submit their application to the FDA. Before an application is accepted for approval, two major regulatory tests described below are applied. 

 

THE DRUG HAD TO TARGET SERIOUS CONDITIONS 

What is a serious condition? If you are a patient almost every disease would be a serious condition. The FDA has clarified this in a guidance document. 

This is a disease or condition which has significant impacts on a person's day-to-day ability to function or even die. 

Clinical judgment has to be made in determining whether a disease is serious or not. 

The judgment is based on the impact of the disease on factors such as the patients' survival and day-to-day functioning. In addition, an assessment is made on the likelihood that the disease will progress to a more severe condition if no treatment is provided. 

There are other three pathways for expedited approval of NDA which require establishment of serious condition. They include fast track, breakthrough therapy and priority review. 

All diseases that are life threatening qualify as serious illnesses but not necessarily for accelerated FDA approval as we will see later. Some will qualify for fast track, breakthrough therapy and priority review but not for accelerated approval.

 

THE DRUG HAD TO BE FOR AN UNMET MEDICAL NEED 

The term "unmet t Medical Need" is used to refer to a medical condition that does not have adequate treatment or diagnosis. It may be for treatment of cancer or a method for better and faster diagnosis of a serious illness. The application of the term "unmet medical need" could be quite broad.

The term "unmet medical need" could be used where there is no available appropriate treatment to the patients. Sometimes a new therapy may be available but unmet medical need may still exist such as when the new reduces the symptoms but not the serious outcome such as progressive disability or progression of the illness. 

 

WHAT THE SPONSOR SHOULD DO

Because many sponsors may want to use accelerated FDA approval, certain pre-qualification criteria have been put into place.

As the accelerated FDA approval application is based on surrogate endpoints. Sponsors should ordinarily discuss with the FDA of the intention to request for accelerated approval. 

The request would help the sponsor to choose the best surrogate endpoints during the clinical trials. Surrogate endpoints are endpoints other than clinical endpoints which take longer to determine for diseases that take long to show a clinical endpoint. 

For example, it might take long to show that a drug prolongs life. Prolongation of life is a clinical endpoint. Decrease in the blood in viral load such as in HIV would be a surrogate endpoint.

Surrogate endpoints include laboratory measurements and images among others. The use of clinical endpoints is however required in the confirmatory clinical trial reports.

By the time this application is being submitted the sponsor should be in a position to discuss the confirmatory clinical trials which should be in progress. 

Without evidence of these confirmatory trials the FDA may be reluctant to approve the requested accelerated FDA approval. The risk to patients is exposure to expensive drugs which may offer no clinical benefits. The sponsor must provide evidence for commitment to complete the pending confirmatory trials.

Does Canada have a similar program to accelerated FDA approval? The Canadian equivalence is called priority review. In this program the sponsor is encouraged to request for priority review status early. The sponsor will get a notice of compliance status with conditions after the application when the only data available is from surrogate end-points. 

The target review period is 200 days. Just as in USA, the sponsor has to submit confirmatory clinical trial data for full compliance without conditions.