Pharmaceutical Regulatory Affairs in the United Arab Emirates

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 Role of Regulatory Affairs in the Pharmaceutical Industry

Key responsibilities of regulatory affairs professionals in the pharmaceutical industry:

• Reviewing and preparing regulatory submissions for new products
• Ensuring compliance with GMP, GCP, and GLP requirements
• Maintaining up-to-date knowledge of regulatory guidelines
• Liaising with regulatory agencies and bodies
• Supporting marketing teams with compliant promotional materials

The Regulatory Framework in the UAE

Key regulatory agencies and bodies in the UAE pharmaceutical industry:

• Ministry of Health and Prevention (MOHAP)
• Ministry of Climate Change and Environment
• Dubai Health Authority (DHA)

Key Regulations and Guidelines

• Federal Law No. 4 of 1983 Concerning Pharmaceutical Products
• Federal Law No. 13 of 2013 Concerning Clinical Trials
• UAE Good Manufacturing Practices (GMP) Guidelines

Challenges and Opportunities

Regulatory affairs professionals in the UAE face:

• Evolving regulatory requirements
• Managing multiple regulatory bodies
• Ensuring international compliance

However, the growing pharmaceutical sector offers excellent career advancement opportunities.

Future Outlook

The pharmaceutical industry in the UAE is expected to continue growing, with increasing focus on research and development, creating ongoing demand for skilled regulatory affairs professionals.

Oncology Drug Approvals - Q2 2021 Report

Key Insights from OncoHealth's Q2 2021 Report

OncoHealth, the main advanced health association focused on the physical, internal, and financial complications of cancer care, has released its Q2 2021 report detailing the FDA's latest approved oncology drugs. This report highlights the increase in accelerated approvals as well as emerging concerns regarding their development.

Accelerated Approvals and Safety Designations

OncoHealth's report reveals that 29 of the approvals featured a safe designated spot asset, while 43 were biomarker inferior. Fifty (seven of 14) new oncology drugs received accelerated approvals in this quarter, an increase from 36 in the same quarter of 2020.

Cost Trends

The costs associated with the drugs receiving accelerated approvals in Q2 2021 ranged from $404 to $336 annually. Over the past two years, the FDA has granted 38 accelerated approvals in oncology.

FDA's Approval Trends

"As the FDA increases its accelerated approvals, a significant number of new drugs are being granted with cautious optimism," stated the Senior Vice President of Pharmacy at OncoHealth. Concerns remain regarding delays in confirming primary issues and the lack of prompt action by the FDA during prior investigations.

FDA Activity Amidst COVID-19

Despite the focus on the COVID-19 pandemic in recent months, the FDA has continued to approve oncology-related drugs. The 14 approvals in Q2 contribute to a total of 34 oncology drugs approved in the first half of 2021, in addition to the 66 oncology-related approvals in 2020.

Emerging Treatments and Biomarkers

OncoHealth's Q2 2021 report also notes that immune checkpoint inhibitors continue to grow in usage, establishing their place as the standard of care in over 17 distinct cancer types. Nearly a third (29) of new oncology drugs in the second quarter of 2021 involved an immune checkpoint asset, up from 25 in the same quarter of 2020.

Trends in Drug Approvals

A notable trend is that one in four FDA approvals now contains a safe designated spot asset. In Q2 2021, 43 of the approved oncology drugs were biomarker inferior. Two of the seven new molecular entities (NMEs) supported in the second quarter of 2021 introduced new molecular targets for advanced/metastatic non-small cell lung cancer (NSCLC).

Future Directions in Oncology

Oncologists are increasingly turning to germline and tumor testing to better inform treatment decisions.

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FDA's Accelerated Approval Process: Benefits and Requirements

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 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.