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.

Egypt Approves Emergency Use of Molnupiravir for COVID-19 Treatment

The Egyptian Drug Authority (EDA) said in a statement that more companies, currently under review, will manufacture the drug by US pharmaceutical giant Merck.

In a separate statement by the Ministry of Health, the head of the EDA mentioned that local companies "have so far succeeded in producing 25,000 Molnupiravir packages, with enough raw materials available to manufacture around 150,000 additional packages."

Egypt is the first country in Africa and the Middle East, and the fourth worldwide, to approve the anti-COVID drug Molnupiravir, according to Acting Health Minister Khaled Abdel-Ghaffar.

Molnupiravir has received emergency use authorization from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) as the first oral capsule to treat COVID-19. It can reduce hospitalizations and deaths by half for patients with mild to moderate COVID-19 illness.

Molnupiravir can cut hospitalizations and deaths by 30% among individuals at high risk of COVID-19, according to Merck.

Molnupiravir will only be allowed in hospitals to ensure it is taken under full medical supervision and according to guidelines set by the relevant scientific committees to guarantee continuous therapeutic follow-up, the EDA said in its statement.

In comments to local newspaper El-Masry El-Youm, the Health Ministry spokesperson said Egypt is expected to receive AstraZeneca's Evusheld COVID antibodies to treat 50,000 patients.

Early in January, the spokesperson said Egypt was also expected to receive Pfizer's Paxlovid pills for the treatment of 20,000 COVID patients by the end of the month.

While Paxlovid and Molnupiravir are used to treat mild to moderate cases during the early stages of infection, Evusheld is designed to prevent COVID infections.

Some studies have found that when taken early in the infection, Paxlovid can reduce the risk of hospitalization or death by up to 89%.

Egypt's import of COVID drugs comes amid a significant surge in cases, with health authorities reporting that Omicron has become the dominant COVID variant across the country.

The World Health Organization recently said that while Omicron is less severe than the Delta strain, it still poses a risk, especially to unvaccinated individuals.

The Health Ministry has urged citizens to register for the COVID vaccine, as it is the best method for reducing deaths and severe infections.

In Egypt's current wave of the pandemic, unvaccinated individuals are three times more likely to be hospitalized due to COVID-19 compared to those who received two vaccine shots, and ten times more likely to be hospitalized compared to those who got a booster shot, according to data released by the Health Ministry on January 15.

So far, Egypt has imported around 132 million doses of various COVID vaccines and opened 1,393 vaccination centers, the acting health minister said during a meeting with the Prime Minister and top health officials last week.

The country has also administered around 60.5 million vaccine doses, including first and second shots, as well as half a million booster shots, the health minister noted.

Additionally, about 206,000 doses have been given to children aged 12 to 15, while around 1.4 million shots have been given to teens aged 15 to 18.

FDA Approved Sancuso Patch for Chemotherapy Patients

SANCUSO is the first and only FDA-approved prescription patch for the prevention of nausea and vomiting in patients getting particular sorts of chemotherapy therapy.

The active medication in SANCUSO, granisetron, gradually disintegrates in the slender layer of adhesive that adheres to the patient's skin and is delivered into their circulatory system more than a few days, working ceaselessly to prevent chemotherapy-induced nausea and vomiting (CINV).

It is applied 24 to 48 hours prior to getting chemotherapy and can prevent CINV for up to five continuous days. Elective oral medicines should be taken a few times (constantly) to convey similar remedial dosages. "In 2020 there were almost 2,000,000 new instances of disease in the U.S.

What's more every year over a large portion of 1,000,000 Americans go through chemotherapy, with many experiencing the symptoms of their treatment. With SANCUSO, patients are given a basic, simple to apply protection arrangement that doesn't need gulping any pills which can be hard for patients encountering queasiness," said, CEO at Cumberland Pharmaceuticals. "We are respected to assume liability for the brand and present it through our business association, guaranteeing that it is conveyed to the patients who need it."

Under the particulars of the arrangement, Cumberland will obtain U.S. Rights to SANCUSO and will accept full business accountability for the product including its marketing, promotion, distribution, manufacturing and medical support activities.

Net sales of the brand in the U.S. Were more than $14 million out of 2020. The financial terms of the procurement incorporate a $13.5 million installment to Kyowa Kirin after shutting, up to $3.5 million in achievements and layered sovereignties of up to 10% on U.S. Net product deals.

Kyowa Kirin will hold international rights, proceeding to convey the product to address oncology patients' necessities all through the remainder of the world. "Since its send off in 2008, we have set up SANCUSO as a significant strong helpful answer for oncology patients the nation over," said, president of Kyowa Kirin North America. "We accept that Cumberland is all around situated to upgrade the worth of the brand and guarantee that this extraordinary item keeps on conveying significant helpful advantages to oncology patients."

Understanding the Impact of Rising API Costs on Drug Pricing

The SME Pharma Industries' Confederation (SPIC) has said that considering the rising cost of active pharmaceutical ingredients (APIs) and excipients, the maximum price tags of medications should be adjusted according to the changing ingredient cost periodically.

In recent months, the cost of bulk drugs has increased significantly. For instance:

• Paracetamol: Increased from ₹350/kg to ₹900/kg
• Carbamazepine: Rose from ₹2,000/kg to ₹5,500/kg
• Ceftriaxone sterile: Increased from ₹6,600 to ₹8,200
• Tazobactam: Jumped from ₹47,000 to ₹55,000

The maximum price tags for drugs have not been adjusted promptly by the National Pharmaceutical Pricing Authority (NPPA), even when the cost of raw materials exceeds the fixed price of the drug. This lack of adjustment has led to quality concerns in the industry.

"Currently, the situation is the worst it has ever been. Legitimate manufacturers are losing market share," said the secretary general of SPIC in a letter to Prime Minister Narendra Modi. The association has consistently warned about over-reliance on China for APIs.

Bulk pharmaceutical wholesalers have been stockpiling raw materials to profit from price hikes, with no government policy to curb this behavior. The Central Drugs Standard Control Organization (CDSCO) could help address this issue.

"Unless API costs are brought under price control, medication prices should fluctuate with API costs. The government must act to ensure affordable quality generics," the SPIC representative concluded.

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.

© 2024 Pharmadeel. All rights reserved.

Turalio FDA Approval for Tenosynovial Giant Cell Tumor (TGCT) Treatment

Image: Turalio FDA approval

The U.S. Food and Drug Administration has granted approval to Turalio (pexidartinib) capsules for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations, and not responsive to improvement with surgery. Turalio is available in 200mg tablets, with a recommended dose of 400mg taken orally twice daily on an empty stomach, at least 1 hour before or 2 hours after a meal or snack.

About Tenosynovial Giant Cell Tumor (TGCT)

TGCT is a rare tumor that affects the synovium (the thin layer of tissue that covers the surfaces of the joint spaces) and tendon sheaths (the membrane that covers tendons, which connect muscle to bone). Although rarely malignant, TGCT causes the synovium and tendon sheaths to thicken and overgrow, leading to damage to the surrounding tissue.

Turalio FDA Designations

The FDA granted this application Breakthrough Therapy and Priority Review designations. Turalio also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.

Warnings and Precautions

The prescribing information for Turalio includes a Boxed Warning about the risk of serious and potentially fatal liver injury. Health care professionals should monitor liver tests before and during treatment. If liver tests become abnormal, Turalio may need to be withheld, the dose reduced, or treatment permanently discontinued, depending on the severity of the liver injury.

Turalio is available only through the Turalio Risk Evaluation and Mitigation Strategy (REMS) Program to ensure its safe use.

Source: FDA, Daiichi Sankyo

GMP and GLP Compliance in Labs: A Guide to FDA Regulations

Overview of GMP and GLP Compliance

The guidelines for food and medications in the United States, portrayed in Title 21 of the Code of Federal Regulations (CFR), are essential to ensure safe and ethical drug administration. Whether you are an academic institution, government agency, or pharmaceutical company, adherence to these principles is required at every step of the drug development process. Failure to comply could lead to serious repercussions, including corporate shutdowns.

Key Aspects of Regulatory Compliance

This guide outlines the essential aspects of regulatory compliance for good manufacturing practices (GMP) and good laboratory practices (GLP) in GxP labs and explains how to achieve and maintain these standards.

FDA Title 21 CFR and the Drug Development Process

The U.S. Food and Drug Administration's (FDA) Title 21 CFR comprises three parts enforceable by the FDA, Drug Enforcement Administration (DEA), and Office of National Drug Control Policy (ONDCP). The sections related to drug development and manufacturing generally fall under the first section.

Key FDA Regulations for Compliance

• Part 11 – Electronic Records and Signatures: Ensures electronic data integrity throughout the drug development process.
• Part 58 – Good Laboratory Practice for Nonclinical Laboratory Studies: Governs the quality and integrity of health data supporting product applications.
• Part 210 – GMP for Manufacturing, Processing, Packing, or Holding of Drugs: Sets the minimum requirements for drug manufacturing to ensure safety, identity, and strength.
• Part 211 – GMP for Finished Pharmaceuticals: Provides guidelines for the preparation of drugs for human or animal use.
• Part 820 – Quality System Regulation: Outlines requirements for device design, manufacture, labeling, and servicing.

Consequences of Non-Compliance

Failure to comply with FDA regulations can lead to inspections, the issuance of Form 483, warning letters, and potentially severe consequences, including product recalls or corporate closures.

Ensuring Compliance in GMP and GLP Labs

Molecular Devices offers a range of tools and services to help labs maintain compliance with GMP and GLP regulations. Our solutions focus on data integrity, installation qualification (IQ), operational qualification (OQ), and preventive maintenance (PM), ensuring your lab equipment is always up to standard.

Ensuring Data Integrity with SoftMax Pro GxP Software

SoftMax Pro GxP Software ensures compliance with FDA 21 CFR Part 11 by providing a system audit trail, tracking all changes with time stamps, usernames, and signatures. This software ensures that only authorized personnel can access and manipulate the system, enhancing data security and compliance.

Additional Services

Molecular Devices also offers Performance Qualification (PQ) and User Acceptance Testing (UAT) to measure the accuracy and repeatability of lab instruments, ensuring reliable and error-free data generation.

© 2024 Molecular Devices. All Rights Reserved.

Drug Regulatory Reforms in India

The proposed reforms in the existing drug regulatory system in India include provisions for manufacturing and stockpiling of non-COVID vaccines during clinical trials. The Health Ministry's May 18, 2020, announcement marked a significant change by allowing the stockpiling of COVID-19 vaccines during clinical trials, which accelerated the availability of vaccines for public distribution.

Impact on COVID-19 Vaccine Manufacturing

Due to this rule, it became possible to manufacture and stockpile the COVID-19 vaccine during its clinical trials. As a result, millions of vaccine doses were made available in a short span of time, saving countless lives. By the end of 2020, the Serum Institute of India (SII) had already produced around 50 million doses of the Oxford-AstraZeneca COVID-19 vaccine, even while waiting for regulatory approval.

Reforms for Non-COVID Vaccines

Given the success of this provision for COVID-19 vaccines, the same approach should be adopted for non-COVID vaccines. The authorization to use the remaining batches from clinical trials for commercial purposes would ensure that these vaccines are not wasted and can serve a greater purpose after proper regulatory approval.

Draft Rules and Future Implementation

In April 2018, the Health Ministry issued draft rules to allow the commercial use of remaining vaccine batches after clinical trials, under certain regulatory forms. However, these draft rules have yet to be implemented. Rapid enforcement of these rules is essential to prevent the destruction of life-saving vaccines.

Prime Minister's Vision for Regulatory Reform

Following Prime Minister Narendra Modi's vision, a high-powered inter-ministerial commission was established in May 2020 to reform India's drug regulatory system. Recommendations from this commission should be implemented quickly to improve the ease of doing business and advance India's global leadership in vaccine production.

Conclusion

The reforms in India's drug regulatory system, if implemented effectively, have the potential to elevate the country's vaccine industry to new heights. With the right regulatory framework, India can continue its role as a world leader in vaccine production and distribution.

Understanding the Drug Development Process

Have you ever wondered where the medicines we take come from? How do doctors determine which drug is suitable for a specific disease? How are medicines able to cure the ailments they are prescribed for? Let’s explore the drug development process from the beginning.

Drug Development Phases

The development of drugs involves clinical research and several phases of testing. These phases are designed to provide evidence for the efficacy and safety of a drug. The process starts with drug design and molecule discovery and progresses through various stages, including animal and human testing.

Pre-Clinical Study

When a drug molecule is identified, it undergoes in vitro (test tube or cell culture) and in vivo (animal) experiments to assess its preliminary efficacy, toxicity, and pharmacokinetics. This phase helps pharmaceutical companies determine which molecules have the greatest potential for further study.

Phase 0 Study

Also known as micro-dosing trials, this phase involves administering single sub-therapeutic doses to a small group of 10-15 human subjects. The goal is to gather pharmacokinetic data to decide whether to proceed with further development. If the data is promising, an Investigational New Drug (IND) application is submitted to the FDA.

Phase I Study

Also known as First-in-Man studies, this phase tests the drug's safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) in 2-100 healthy subjects. It includes:

• Phase Ia: Single ascending dose studies.
• Phase Ib: Multiple ascending dose studies.

Phase II Study

This phase involves enrolling over 100 diseased subjects to evaluate the drug’s efficacy and safety over a longer period. This phase is also known as "Proof of Concept" or "Pilot" studies and can result in the drug’s failure if the results are not as expected or if there are significant side effects.

• Phase IIa: Pilot study to assess clinical efficacy or biological activity.
• Phase IIb: Dose-finding study to determine the optimal dose with minimal side effects.
• Combined trials, such as Phase I/II, can also be conducted to evaluate efficacy and toxicity.

Phase III Study

This phase involves large-scale testing to confirm the drug’s effectiveness, monitor side effects, and compare it with existing treatments. Data from Phase III trials is critical for regulatory approval.

Phase IV Study

Post-marketing surveillance ensures the drug’s long-term effectiveness and safety once it is available to the public. This phase helps to monitor any long-term effects or rare side effects.

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