Issue 18: Pharmaceutical regulatory roundup

BY DR TIM SANDLE  | 20 February 2024



Catch up with the latest news from around the pharmaceutical industry with issue 18 of our regulatory review, curated by Dr Tim Sandle.


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Generic medicines: New FDA guidance


The core content of an Abbreviated New Drug Application (ANDA) presents information on the safety, effectiveness and quality of the generic drug. This information must be equivalent to the brand-name drug the application references (the “reference listed drug”). The ANDA differs from a new drug application in that it is not required to include preclinical (animal and in vitro) or human clinical trial results. Instead, the emphasis is on bioequivalence so that more affordable medicines can be introduced onto the market without repeating clinical trials to establish safety and efficacy.


A successful ANDA approval allows the applicant to manufacture and market the generic drug as a lower-cost alternative to the brand-name drug. All approved products, both innovator and generic, are listed in the FDA's “Approved Drug Products with Therapeutic Equivalence Evaluations” (commonly known as the Orange Book).


To improve the quality of applications and ensure improved consistency, the FDA has developed guidance to assist applicants in preparing and submitting amendments to tentatively approved ANDAs or in seeking final approval (“ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs, U.S. Department of Health and Human Services”). 




Biological evaluation of medical devices


The process and requirements for the toxicological risk assessment of medical device constituents is outlined in a revised ISO standard - ISO 10993-17 “Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents.”


The guideline also considers “the methods and criteria used to assess whether exposure to a constituent is without appreciable harm.” 


The process described by the International Organization for Standardization (ISO) within ISO 10993-18, is relevant to chemical characterisation of materials, such as extractable data or leachable data (E&L). This is when a toxicological risk assessment of either the compositional information or analytical chemistry data (e.g. extractable data or leachable data) are required to determine whether the toxicological risks related to the constituents are negligible or tolerable.


ISO standards require purchasing via national standards organisations or directly from ISO: 




Healthcare management


Healthcare administrators today find themselves at the forefront of a demanding and transformative field, where the pursuit of excellence in patient care is non-negotiable. In a health industry landscape facing evolving regulations, escalating costs and an increasing emphasis on patient outcomes, the need for effective management of quality in healthcare organisations has never been more critical.


Quality care for all promotes equal opportunities for good health, irrespective of socioeconomic status. This article explores the formidable obstacles and challenges that healthcare administrators encounter on a daily basis, highlighting the indispensable role of quality management in addressing these issues and ensuring the highest standards of care delivery.


ISO 7101:2023 “Healthcare organization management - Management systems for quality in healthcare organizations” is the first management system standard for quality in healthcare organisations. It prescribes requirements for a systematic approach to sustainable, high-quality health systems.


Read more: 




Ophthalmic drug products 


A new US FDA draft guidance discusses certain quality considerations for ophthalmic drug products (i.e., gels, ointments, creams and liquid formulations such as solutions, suspensions, and emulsions) intended for topical delivery in and around the eye. Specifically, the guidance discusses microbiological considerations.


The draft guidance is titled “Quality Considerations for Topical Ophthalmic Drug Products”.


The guidance also includes approaches to evaluating visible particulate matter, extractables and leachables, and impurities and degradation products. Also contained within the guidance are recommendations for design, delivery and dispensing features of Container Closure Systems (CCSs).


The draft guidance can be accessed here: 




Viral safety


The U.S. Food and Drug Administration (FDA) has made available the final guidance “Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin.”


The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance is intended to describe risk-based principles and mitigation strategies to assure the viral safety of biotechnology products, including the data necessary to submit a marketing application. 


The guidance also finalises the updates based on advances in scientific knowledge and regulatory expectations to the first version of the ICH guidance for industry “Q5A Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin,” issued in September 1998. 


Lastly, the guidance replaces the draft guidance “Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin” issued on November 14, 2022.





Remote inspections


The U.S. FDA has issued a draft guidance entitled “Conducting Remote Regulatory Assessments--Question and Answers.”


The FDA is issuing the draft guidance to describe the agency’s current thinking regarding its use of Remote Regulatory Assessments (RRAs) in order to increase industry’s understanding of RRAs and facilitate their process for conducting RRAs. The FDA has used RRAs to conduct oversight, mitigate risk, meet critical public health needs and help maximise compliance of FDA-regulated products. This draft guidance provides answers to frequently asked questions regarding what RRAs are, when and why FDA may use them and how FDA may conduct them, among others.


This draft guidance is consistent with FDA’s good guidance practices regulation (21 CFR 10.115). When finalised the guidance will represent the current thinking of FDA on “Conducting Remote Regulatory Assessments.” It does not establish any rights for any person and is not binding on the FDA or the public. Firms can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.






Advanced manufacturing technologies


The U.S. FDA has indicated that it encourages the early adoption of Advanced Manufacturing Technologies (AMTs), especially technologies that have the potential to benefit patients by improving manufacturing and supply dependability and optimising development time of drug / biological products. 

These technologies can be integral to ensuring quality and supporting a robust supply of drugs that are life-supporting, life-sustaining, of critical importance or in shortage. AMTs can directly improve product quality through higher capability manufacturing designs and enhanced controls (e.g., leading to fewer human errors). 

A new draft guidance provides recommendations to persons and organisations interested in participating in FDA’s Advanced Manufacturing Technologies Designation Program, which is intended to facilitate the development of drugs, including biological products, manufactured using an AMT.




Regulatory Procedure Management


The European Medicines Agency (EMA) has issued a regulatory document titled “RPM for PLM (Regulatory Procedure Management for the Product Lifecycle Management) – Frequently Asked Questions and Answers”.


As the current submission management system used at EMA (SIAMED) is being decommissioned, IRIS will become the new submission management system and will become the communication portal between the EMA, EU Network and applicants. 





Investigating the hepatitis E virus


The hepatitis E virus (HEV) is the most common cause of acute viral liver inflammation (viral hepatitis). Every year, there are about 15 to 110 million active cases worldwide, which result in about 70,000 deaths. There are no vaccines or targeted treatments against HEV authorised in Europe.


The therapeutics available are not specific, have strong side effects and can lead to resistance. A research team at the Paul-Ehrlich-Institut has identified certain vesicle structures and proteins that could be targets for treatment and contribute to a new understanding of viral genome transmission.


The guidance can be found here:




EMA Annex 1 Q&A discusses bioburden considerations


The European Medicines Agency (EMA) has published four new Q&As to its catalogue of Annex 1 questions. These included two questions focusing specifically on bioburden level and bioburden sampling.




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