Pharma GMP News of the Week: 19-February-2023
Period: February 12, 2023 to February 18, 2023
MHRA Inspectorate Blog published 25+ Frequently Asked Questions on related to “Manufacture of Investigational Medicinal Products”
Date of news: February 3, 2023
MHRA Clinical Trials and GMP and GCP Inspectors collaborate closely, and they frequently offer assistance in response to stakeholder questions about the production, importation, labelling, licencing requirements, and general handling of Investigational Medicinal Goods (IMPs).
This “frequently asked questions” blog post about the production and distribution of IMPs was originally published by us in 2016. It was based on a prior MHRA website article. We decided it would be good to examine and update this blog because there have been some changes since it was first published, such as the implementation of an import oversight procedure for IMPs with QP certification entering Great Britain from authorised nations.
Source: Manufacture of Investigational Medicinal Products – Frequently Asked Questions – MHRA Inspectorate
News from EDQM “Public consultation on Ph. Eur. rabbit pyrogen test replacement texts in Pharmeuropa 35.1”
Date of news: February 13, 2023
For public discussion in Pharmeuropa 35.1 with a comment deadline of March 31, 2023, the European Pharmacopoeia (Ph. Eur.) has published the 59 texts (1 new general chapter, 5.1.13. Pyrogenicity, and 58 revised texts) involved in the rabbit pyrogen test (RPT) replacement strategy.
These texts, which cover a wide range of subjects like human-use vaccines, blood products, antibiotics, radiopharmaceuticals, and containers, have been updated to swap out the RPT for an alternative in vitro test like the monocyte activation test (MAT) or another method that is sympathetic to animal welfare. Their release represents an important development in the plan established by the Ph. Eur. Commission in June 2021, which is expected to eventually result in the total replacement of the rabbit pyrogen test (RPT) in the Ph. Eur., anticipated within the next three years.
In more detail, this goal and how it will be accomplished are covered in the pyrogenicity strategy paper that was released in September 2022.
News from EDQM “The European Pharmacopoeia (Ph. Eur.) 10th Edition has been obsolete since 1 January 2023”
Date of news: February 14, 2023
Since January 1, 2023, the 10th Edition of the European Pharmacopoeia (Ph. Eur. As a result, starting on January 31, 2023, no one can access the 10th Edition online or any of its predecessors, including the Ph. Eur. archives for 10th Edition users.
On the specific European Pharmacopoeia online site, subscribers can access the Ph. Eur. 11th Edition and its supplements. Users with a current membership (11th Edition) can still consult out-of-date Ph. Eur. materials in the Ph. Eur. archives accessible through the new site..
EMA Published highlights of 2022 on Human medicines
Date of news: February 16, 2023
89 medications were suggested by the EMA for marketing authorization in 2022. Of them, 411 contained a novel active ingredient that had never before received authorization from the European Union (EU). A list of novel medications that have made substantial strides in their therapeutic fields is included in the PDF icon overview of the 2022 main recommendations that was released today.
EMA and the EU Member States regularly monitor a drug’s quality and benefit-risk balance after the European Commission grants it approval and authorises it for use in patients. When necessary, they take appropriate regulatory action. A limited number of batches may be recalled, a medicine may be suspended or removed, or the product information may be changed. An overview of some of the most notable safety-related recommendations is also included in the document.
FDA Published Draft Guidance “Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA”
Date of news: February 17, 2023
In accordance with section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)), this guidance offers recommendations to the industry on product-specific guidance (PSG) meetings between FDA and a prospective applicant who is preparing to submit to FDA or an applicant who has already submitted an abbreviated new drug application (ANDA). The Generic Drug User Fee Amendments (GDUFA) Reauthorization Performance Objectives and Program Enhancements Fiscal Years 2023–2027, in particular, give information on requesting and conducting PSG meetings with FDA (PSG teleconferences, pre-submission PSG meetings, and post-submission PSG meetings) (GDUFA III commitment letter). Additionally, this advice aims to provide guidelines for managing PSG meetings efficiently, ensuring that they are scheduled and run in compliance with the