GMP News Drug Safety/Pharmacovigilance


CBD is controlled as a medicine in Finland

The Finnish Medicines Agency (Fimea) recently stated that Cannabidiol (CBD) is controlled as a medicine in Finland.



Clinical Trials Regulation Questions & Answers Version 2.3

The European Commission (EC) published an updated Version 2.3 of the Questions & Answers relating to the Clinical Trials Regulation.



France Takes Further Steps Regarding Medical Cannabis

The French National Agency for Medicines and Health Products Safety carries on the work on medical cannabis started in 2018 and has now published a dossier on cannabis for medical use.



Medicinal Products for Human Use: EMA's Highlights 2019

The EMA has published the highlights for human medicines for 2019. These include 30 new APIs and one cannabis product.



From GVP to GMP: MHRA´s tips for QPs to stay compliant

The MHRA recently posted three top tips for protecting patients and staying compliant when introducing updates to patient information leaflet.



Ph. Eur. Draft Chapter for PA Contaminants in Herbal Drugs

A new Ph. Eur. chapter 2.8.26. Contaminant pyrrolizidine alkaloids (PAs) has been proposed for comment in the recent issue of  Pharmeuropa. The scope of this new general chapter covers trace analysis of target PAs in herbal drugs, herbal drug preparations and herbal medicinal products.



FDA continues to warn companies for illegally selling CBD products

The FDA recently issued 15 warning letters to companies for illegally selling products containing cannabidiol (CBD).



FDA works on regulatory pathways for CBD products

Cannabidiol (CBD) is currently marketed in a variety of product types, such as oil drops, infused pouches, capsules, syrups, teas and topical lotions and creams. Therefore, the FDA is working on the evaluation of regulatory policies related to cannabis and cannabis-derived ingredients.



New FDA guidance on Child-Resistant Packaging

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.



What is a Combination Product?

The FDA released a final guidance on postmarketing safety reporting for combination products to further clarify what a combination product is and how applicants can comply with the rules on postmarketing safety reporting requirements (PMSR).



French pilot programme for medical cannabis

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.



New structure of Ph. Eur.´s packaging section

The numbering of the Ph. Eur. packaging section 3 has been changed for the 10th Edition following the creation of the new chapter 3.3. Containers for human blood and blood components, and materials used in their manufacture; transfusion sets and materials used in their manufacture; syringes.



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.



The ICH publishes E8(R1) Draft Guideline for comment

The ICH E8(R1) draft Guideline on General Considerations for Clinical Trials reached Step 2b of the ICH Process in May 2019 and has entered the public consultation period.


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