BY DR TIM SANDLE | 20 NOVEMBER 2023
Catch up with the latest news from around the pharmaceutical industry with issue 15 of our regulatory review, curated by Dr Tim Sandle.
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The European Medicines Agency has updated its guidance on the parallel distribution of medicinal products. ‘Parallel distribution’ refers to Centrally Authorised medicinal Products (‘CAPs’) put on the market of one member state that can be marketed in any other member state by a distributor, independently of the marketing-authorisation holder.
To access the guidance, see: https://www.ema.europa.eu/en/human-regulatory/post-authorisation/parallel-distribution/frequently-asked-questions-about-parallel-distribution
Questions and answers for biological medicinal products
The European Medicines Agency has updated its guidance on biological medicinal products (which takes the form of a ‘Q&A’ document). This includes:
- Whether the dossier should mention reprocessing (which it does, at specific stage codes)
- Raw materials and media components
- The requirement to include identifiers for in-house analytical methods in the specification table supplied in a dossier. Method validation summaries are required for methods not contained in the European Pharmacopeia (with compendial methods, the Ph. Eur. monograph can be referred to)
- Advice around the testing or use of validation data in relation to process related impurities
- Host Cell Protein (HCP) testing guidance
- Advice on biosimilar medicinal products
- Guidance on Antibody Dependent Cell-mediated Cytotoxicity (ADCC) activity
- Polysorbate, if applicable, in the finished product specification
- Low endotoxin testing for product formulations that contain a combination of a surfactant (e.g. polysorbate) and a chelator (e.g. EDTA, citrate, phosphate, histidine). Studies investigating Low Endotoxin Recovery (LER) should be submitted in the dossier
- Detailing any excipients manufactured using recombinant technology
The Q&A can be accessed here: https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-guidelines/biologicals/questions-answers-biological-medicinal-products
FDA guidance on remote inspections
The US FDA has issued a draft guidance document on remote inspections, titled ‘Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities: Guidance for Industry’.
FDA describes how it requests and conducts voluntary remote interactive evaluations at facilities where drugs are manufactured, processed, packed, compounded, or held and at drug facilities covered under FDA’s bioresearch monitoring program.
This follows the practices that were required to be undertaken during the COVID-19 pandemic. Having developed the tools, the FDA is proposing using remote inspections as an additional tool.
The following platforms are required: Microsoft Teams, Zoom or Adobe Connect.
The draft guidance can be found here: https://www.fda.gov/media/173286/download
Regulatory recognition routes
MHRA has issued a new document, titled ‘Guidance published on the new international regulatory recognition routes for medicines approvals’.
This guidance informs the sector on how they can use the scheme to apply for a medicine licence in the UK, following approval by trusted regulatory partners in Australia, Canada, the European Union, Japan, Switzerland, Singapore and the United States.
To access, see: https://www.gov.uk/government/publications/international-recognition-procedure
Five guiding principles for machine learning-enabled medical devices
The MHRA, together with US Food and Drug Administration (FDA) and Health Canada, has collaborated to identify five guiding principles for the development of Predetermined Change Control Plans (PCCPs).
These guiding principles for PCCPs aim to remove the regulatory burden for developers of Machine-Learning-enabled Medical Devices (MLMDs), enabling reallocation of resources to improve product performance for patients.
This fits in with current guidance on Good Machine Learning Practice (GMLP).
- Focused and bounded: Describing specific changes that a manufacturer intends to implement
- Risk-based: The intent, design and implementation of a PCCP are driven by a risk-based approach that adheres to the principles of risk management
- Evidence-based: Demonstrating that benefits outweigh the risks throughout the product lifecycle
- Transparent: Provide clear and appropriate information and detailed plans for ongoing transparency to all stakeholders, from patients to healthcare professionals
- Total Product Lifecycle Perspective: Improve the quality and integrity of a PCCP by continually considering the perspectives of all stakeholders
The guidance can be found here: https://www.gov.uk/government/news/mhra-and-international-partners-publish-five-guiding-principles-for-machine-learning-enabled-medical-devices
MHRA Corporate Plan
Readers who are keen on keeping abreast of GxP developments might be interested in this quote from the MHRA Corporate Plan 2023-2026: “Introduce new guidance and legislation, building our status as an independent regulator in a global environment, to ensure the UK remains a great environment to develop novel and innovative medical products.”