GMP News - Herbal Medicinal Products (incl. Cannabis)

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.

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?".

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?

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.

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.

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? 

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.