GMP News Drug Safety/Pharmacovigilance

21.04.21

No Distribution of CBD Products Allowed?

According to recent decisions of two Administrative Courts in Germany, Berlin and Hamburg, food supplements containing cannabidiol may not be marketed without further action.

more

21.04.21

Track & Trace: Amendment of the Delegated Regulation on Safety Features

On 17 March 2021, the Delegated Regulation (EU) 2021/457 was published in the Official Journal of the European Union. It amends the Delegated Regulation 2016/161 regarding an exemption from the obligation for wholesalers to decommission the unique identifier (UI) of medicinal products exported to the UK.

more

14.04.21

Switzerland aims to Facilitate Access to Medicinal Cannabis

The Swiss Narcotics Act is to be amended. Among other things, the amendment provides that cannabis-based treatments can be prescribed directly by doctors without having to obtain an exceptional authorization from the Swiss Federal Office of Public Health. In addition, cultivation and export are to be permitted.

more

07.04.21

Revised Ph. Eur. Chapter 3.2.9. Rubber Closures

A general revision of Ph. Eur. Chapter 3.2.9 "Rubber Closures" has been proposed in Pharmeuropa 33.2. In particular the proposal includes changes to the sections regarding composition changes and extractable elements, functionality & fragmentation testing.

more

30.03.21

Post-Authorization Safety Studies - Recent Inspection Findings

The MHRA recently published inspection findings in the conduct of post-authorization safety studies (PASS). In particular, the agency observed significant breaches of the study protocol for the MAHs non-interventional PASS during inspection at a study site.

more

30.03.21

How to Classify Changes to Ongoing Clinical Trials

The European Commission published an updated Version 3 of the Questions & Answers relating to the Clinical Trials Regulation. Amongst others, the new version covers the classification of changes to ongoing clinical trials.

more

30.03.21

Reference Safety Information in Clinical Trials

The MHRA GCP inspectorate has continued to see non-compliance in reference safety information in clinical trials. In particular, the agency is still seeing unreported SUSARs and absence of adequate risk mitigation measures due to incorrect use of the RSI.

more

24.03.21

Cannabis Glossary and GACP Revision

EMA´s Committee on Herbal Medicinal Products published the 2021 HMPC Work plan. Amongst others the HMPC plans to establish a Cannabis glossary and to revise the GACP guidelines.

more

24.03.21

New THC Threshold for Hemp Products

The German Federal Institute for Risk Assessment has issued a new statement recommending that the assessment of hemp-based food products be based on the EFSA-derived acute reference dose of 1 microgram Δ9-THC/kg body weight.

more

23.03.21

Pharmacovigilance Inspection Metrics

The MHRA GVP inspectorate recently published their latest inspection metrics for the period from April 2019 to March 2020. The highest number of all findings in the reporting period related to risk management followed by quality management systems.

more

11.03.21

New FDA Guidance for COVID-19 Packaging Changes: Glass Vials and Stoppers

COVID-19 injectable products may need some changes to the primary packaging components (e.g., glass vials and stoppers) due to supply chain issues affecting their availability. Therefore, the FDA has issued a new guidance with recommendations for the appropriate reporting category and the content of postapproval change submissions.

more

03.03.21

Ph. Eur. Adopts New General Chapter on Contaminant Pyrrolizidine Alkaloids

The Ph. Eur. Commission adopted a new Ph. Eur. general chapter on contaminant pyrrolizidine alkaloids. The chapter will be implemented on 1 January 2022.

more

24.02.21

UK Guidance on Limits for Controlled Cannabinoids in CBD Products

Extracts or isolates containing Cannabidiol are used in cosmetics and food supplements supplied to the UK market. One question still remains: How to interprete the 1 mg UK limit for controlled cannabinoids?

more

09.12.20

UN Commission Reclassifies Cannabis

The United Nations (UN) Commission on Narcotic Drugs (CND) has decided to reclassify cannabis. With this, the Commission followed the WHO recommendation of 2019.

more

02.12.20

Will CBD be Controlled as a Narcotic?

Will Cannabidiol be controlled as a narcotic in the future? This question is currently intensively discussed. The European Court of Justice recently released their opinion.

more

GMP Newsletter

Sign up for the free of charge newsletters.

Sign up now!

GMP Conferences by Topics