Evaluation of the Immunogenicity of Therapeutic Protein Products - FDA Scientists developed a new Tool
For the important assessment of possible immune responses to therapeutic protein drugs, FDA scientists developed a new mathematical tool to calculate the expected risk of producing antibodies against the biological drug.
ATMP from Third Countries - New Q&A Paper on Batch Release published
With a new Q&A document, the EMA has provided information on the release of Adavanved Therapy Medicinal Products (ATMP) imported into the EU by the Qualified Person without batch re-testing.
The updating of two important documents by the EDQM reflects the current practice of the CEP procedure. Read more about the competencies and responsibilities of the various bodies in the CEP application procedure and about the code of practice for assessors and inspectors.
The FDA published a new guidance on Child-Resistant Packaging (CRP). The guidance is intended to assist applicants, manufacturers, packagers, and distributors who include CRP statements in their drug product labeling.
The USP´s General Chapters—Packaging and Distribution Expert Committee provided an overview of USP´s current packaging standards-strategy in the curent issue of Pharmacopeial Forum. The stimuli article covers USP general chapters related to the suitability for use for materials of construction including plastics and elastomers.
FDA's promotion for cell and tissue products - the TRG Rapid Inquiry Program (TRIP)
With an additional program to support manufacturers of cells, tissues and cell-based products, the FDA is trying to accelerate its promotion of the development of regenerative therapies.
EMA publishes Draft on Quality Requirements for Combination Products
The European Medicines Agency (EMA) has published a draft guideline on quality requirements for combinations of medicinal products and medical devices (so-called Drug Device Combinations - DDCs). What does the draft contain?
The USP is currently introducing some changes to the format of the USP and to its online platforms. Amongst others the USP plans to discontinue printing the USP-NF in the current format.
The objective of the French pilot programme is to follow the recommendations of the CSST to evaluate cannabis prescribing and dispensing, and to collect safety and efficacy data. However, medical cannabis is not expected to be legalized in France prior to the end of 2021.
New Zealand proposes new legislation for medical cannabis
New Zealand released a proposed regulatory approach for medical cannabis. The implementation of the medical cannabis program is anticipated to start in the first quarter of 2020. In addition, the document proposes two options for GMP.
Canada´s New Regulatory Approach for Cannabis Products
Health Canada proposes a regulatory pathway for a new class of cannabis products referred to as Cannabis Health Products that would not require practitioner oversight.