New Regulation on Blood, Blood Products and Plasma
News on the Regulation on standards of quality and safety of substances of human origin (SoHO). The regulation are intended to help ensure that the donation and processing of blood, blood products and plasma reflect the latest legal, political and scientific standards.
EMA and FDA publish Q&A Document on their accelerated Approval Programmes
In December, the EMA and U.S. FDA published a joint Q&A document on accelerated approval of important innovative medicines and therapies entitled: "EMA-FDA joint Q&As on Quality and GMP aspects of PRIME/Breakthrough therapy applications".
FDA Draft Guidance on Potency Assays for Cellular and Gene Therapy Products
At the end of December, the FDA published a new draft guidance document on potency assays for Cell and Gentherapeutics. In addition to recommendations for potency testing, this guidance is also intended to help with the overall strategy for ensuring potency.
WHO Draft Working Document on Bioanalytical Method Validation published for Comments
The World Health Organization (WHO) has published a draft working document entitled Bioanalytical Method Validation and Study Sample Analysis (QAS/23.925). Comments should be submitted by 21 January 2024.
EDQM's new Reference Substance for Hepatitis C Virus
Following the successful completion of the Biological Standardisation Programme study to establish Hepatitis C Virus (HCV) Biological Reference Preparation (BRP) batch 2 for nucleic acid amplification techniques (NAT), the result has been published in the online journal Pharmeuropa Bio & Scientific Notes: "Establishment of Ph. Eur. Hepatitis C Virus RNA for NAT assays BRP batch 2".
In cooperation of the German Medical Association and the German Paul-Ehrlich-Institut, the existing guideline on haemotherapy for the collection of blood and blood components and the use of blood products has been adapted according to the latest legal, political and scientific status.
EMA revises Guidance on Development, Production, Characterization and Specification for Monoclonal Antibodies and related Products.
In the context of technical and scientific developments in the field of certain products containing monoclonal antibodies, the EMA is revising its guidance document "Development, production, characterisation and specifications for monoclonal antibodies and related products" and other related documents.
USP Briefing on Mass Spectrometry-Based Multi-Attribute Method for Therapeutic Proteins
Publications in the'USP Proposals PF 49_5 also include a draft chapter <1060> "Mass Spectrometry-Based Multi-Attribute Method for Therapeutic Proteins".
BfArM/PEI: Guideline "Designation of Medicinal Products" published
The German BfArM (Federal Institute for Drugs and Medical Devices) and the German PEI (Paul Ehrlich Institute) published version 8.2 of the guideline on the designation of medicinal products at the end of July, which can be viewed on both websites of the institutes. The above-mentioned guideline was fundamentally revised in 2023 and applies exclusively to medicinal products for human use. It is intended to support marketing authorisation holders and applicants in the selection of the designation of the respective medicinal products.
EMA's Questions and Answers on the Biological Medicines Marketing Authorisation Dossier Published
Biological medicinal products are gaining more and more interest. Due to the ever increasing complexity and diversity within these medicinal products, more questions arise. The EMA has now published a Q&A document to support the marketing authorisation holders presenting the information in the dossier correctly.
The FDA has published its considerations regarding CGT products in a new draft guidance. The purpose of this guidance is to provide recommendations for managing manufacturing changes and assessing comparability for both investigational and approved human CGT products, taking into account the unique challenges that apply to these products.
Publication of EMA Document on the Establishment of a Guideline on mRNA Vaccines
More and more authorities are trying to create regulations for the production of new technologies by publishing guidelines. In this case, the European Medicines Agency (EMA) is asking for assistance in developing a guideline on the manufacturing of mRNA vaccines.
2nd Version of the USP Draft Guidance on mRNA-based Therapeutics
Because the application of mRNA technology is relatively new, regulatory guidelines and industry standards to govern non-compatible aspects of mRNA quality during development and manufacturing are still evolving. The USP has now defined standards and is seeking input during the comment period on a new draft guidance version for the analysis of mRNA.