EMA´s HMPC published the HMPC Work plan for 2022. Amongst others, the HMPC plans to establish a Guidance on New Manufacturing Techniques addressing, for example, supercritical CO2-extracts.
Herbal Drugs: Concept Paper on GACP Revision Published
EMA´s HMPC published the concept paper on the revision of the guideline on good agricultural and collection practice for starting materials of herbal origin. Amongst others, the revision will address the need for clarification regarding GMP vs GACP.
CMDh: Adjustments to the Guide for Electronic Submissions (eAF)
A new version of the "Module 1: Administrative information Application form - User guide for the electronic application form for a Marketing Authorisation" was prepared in December 2021 and has now been published on the HMA (Heads of Medicines Agencies) website. This document is intended to serve as a supporting guide for the preparation of the electronic application form for the submission of medicinal products for human use and for the registration of traditional herbal medicinal products.
How can you stay up to date with the ongoing changes in the GMP world? This question is frequently addressed during ECA courses and conferences. ECA´s weekly GMP Newsletter informs you about all relevant updates in the GxP arena.
Final EMA Guidelines on Quality Requirements for IMPs
The final EMA Guidelines on the quality requirements for IMPs (pharmaceutical and biopharmaceutical drugs) have been released on the EMA website together with an overview of comments received on the draft guidelines published last year. Many of the comments related to the question "What is a Non-substantial Modification?".
Herbal Drugs: Ph. Eur. Cannabis Monographs and other relevant Topics
EMA´s Herbal Medicinal Products Committee (HMPC) released the minutes for the HMPC meeting held in November 2021. Amongst others, the HMPC noted three new Ph. Eur. Cannabis Monographs for flowers and extracts in the pipeline. Other relevant topics were nitrosamines, GACP revision and elemental impurities in herbal medicinal products.
The EMA HMPC has prepared a new question and answer on herbal medicinal products, which has been included in the practical guidance for marketing authorization holders on the subject of contamination by nitrosamines. Does a nitrosamine risk assessment also have to be carried out for herbal medicinal products?
USP Proposal for Contaminant Pyrrolizidine Alkaloids
A new USP chapter <1567> on pyrrolizidine alkaloids (PAs) is being proposed. It discusses some analytical methods and existing challenges to measure PA contaminants in herbal medicinal products.
Because there is no existing USP monograph for this drug substance, a new monograph for Cannabidiol (CBD) is being proposed. It defines that CBD is obtained from Cannabis sativa.
Herbal Reference Standards - What are Active and Analytical Markers?
Active and analytical markers are used for release and stability testing of herbal substances, preparations and HMPs. The EMA provides guidance on the selection of markers in a reflection paper on markers used for quantitative and qualitative analysis.
The EMA committee adopted a concept paper for the revision of the Guideline on Good Agricultural and Collection Practice (GACP). Interested parties are invited to provide comments by 15 March 2022.
HMPC adopts revised Quality Guidelines for Herbal Medicinal Products
EMA´s HMPC adopted the revised Guidelines on Quality and Specifications for herbal substances, herbal preparations and herbal medicinal products. Will a written GACP declaration for the herbal substance now become a requirement?
Medical use of cannabis has been legalized in Panama in October 2021. The new regulatory framework allows the use and controlled access to medical cannabis for therapeutic, medical, veterinary, scientific and research purposes.
The European Commission sets new limits for Cadmium and Lead in certain Foodstuffs and Food supplements. Products placed on the market before the entry into force of the new regulations and not complying with the new maximum levels should only be allowed to remain on the market for a limited period of time.
