On the 24th of March 2023, the United Kingdom and the European Union formally adopted the Windsor Framework agreement concerning Brexit for Northern Ireland. This agreement sets out arrangements to solve problems and challenges following the exit of Great Britain from the EU. The new version of the document introduces solutions that will make the […]
On 26 May 2023, the European Medicines Agency (EMA) published the draft ICH E6 (R3) guideline on good clinical practice (GCP) – step 2b and the template for comments to the ICH E6 (R3) guideline on good clinical practice.
The document has been submitted for public consultation and the comments will be collected until September 26, 2023. Stakeholders from ICH member countries/regions may submit comments to the relevant regulatory authorities, noting the comment deadline indicated under the draft Guidance.
The CEP, as you know, is a “Certificate of suitability to the monographs of the European Pharmacopoeia“. As we can read on the EDQM (European Directorate for the Quality of Medicines and HealthCare) website it is not mandatory, but the preferred option for demonstrating that a substance used in the preparation of medicinal products complies with the European Pharmacopoeia specifications according to the Note for Guidance on summary
The US Food and Drug Administration (FDA) on Tuesday released two new warning letters for active pharmaceutical ingredient manufacturers Badrivishal Chemicals & Pharmaceuticals and Lumis Global Pharmaceuticals, both sent 2 March. The letter for Talegaon Dabhade, India-based Badrivishal follows a three-day inspection from last August in which FDA uncovered that the site’s water purification system […]
EMA experts meet with African regulators to discuss opportunities for collaboration. How to improve the availability of high quality, safe and effective medicines to patients in countries beyond Europe and how to make better use of existing tools? These were two of the questions discussed at a workshop jointly organised by the European Medicines Agency […]
Release of documents on two medicines temporarily halted.EMA’s appeals against interim measures are dismissed by Court of Justice.The Vice-President of the Court of Justice of the European Union has dismissed two appeals by the European Medicines Agency (EMA) against interim orders of the President of the General Court, thus upholding the suspension of the release […]
This guidance is intended to assist applicants in developing labeling for cardiovascular outcome claims for drugs that are indicated to treat hypertension. With few exceptions, current labeling for antihypertensive drugs includes only the information that these drugs are indicated to reduce blood pressure; the labeling does not include information on the clinical benefits related to […]
The British inspectorate MHRA has recently published an interpretation that goes into detail on the use of health based exposure limits and explains the cases where EMA’s new concept can be applied. One essential element of that concept is EMA’s Q&A Paper describing when a product should be classified as highly active. http://www.gmp-compliance.org/gmp-news/mhras-interpretation-of-cross-contamination-pdes
During the last months, we reported several times about the current activities of the EMA and European Commission relating to the new GMP Guideline document for Advanced Therapy Medicinal Products ( e.g. “European Commission: Draft Guideline GMP for ATMP open for stakeholder consultation” and “GMP for ATMP – two Public Rounds of consultation and still […]
The new MRA Agreement between the EU and the USA on the mutual recognition of GMP inspections is being discussed in depth. One shouldn’t conclude though that the inspection pressure would decrease now because of the recognition of EU inspections. There is a series of exceptions to look out for. The FDA will first ask […]
A draft of Ph. Eur. chapter 3.1.13. Plastic additives has been published for comment in Pharmeuropa 29.2. The chapter has been revised following the identification of di(2-ethylhexyl)phthalate as a substance of very high concern (SvHC) according to the criteria of Article 57 of regulation (EC) 1907/2006 (REACH). http://www.gmp-compliance.org/gmp-news/packaging-pharmeuropa-draft-chapters-regarding-pvc
In April 2017 the European Medicines Agency (EMA) has released a draft guideline on good clinical practice compliance in relation to trial master file (paper and/or electronic) for content, management, archiving, audit and inspection of clinical trials. The draft has been adopted by the GCP Inspectors Working Group (GCP IWG). The public consultation period has started […]