News & Events
Don’t miss a chance to influence the regulatory settings for orally inhaled products!
The end of October is coming. While many of us prepare Halloween decorations and stock up on candies, regulatory experts, mainly involved in the field of respiratory tract diseases, must not forget that 30/10/2024 is the deadline for submission of commentst the EMA Draft guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled […]
European Commission Guidelines: Stakeholder Consultation on Variations Classification
The European Commission is reviewing the rules governing the procedures for post-authorisation changes to the terms of a marketing authorisation for human medicines. EMA, HMA and the European Commission have announced a proposal for stakeholder consultation on the new guidelines for the classification of variations in marketing authorizations for medicinal products for human use. These […]
Attention! End of the transitional periods for the application of the Medical Devices Regulation
According to Medical Devices Regulation (MDR), May 26th 2024 is the end date of the transition period for legacy of devices that do not meet the MDR conditions. After this date, it will be possible to place on EU market only new medical devices for which the manufacturer have submitted an application for conformity assessment […]
EMA: Guideline on the Development and Manufacture of Synthetic peptides.
On 12 October 2023, the European Medicines Agency (EMA) published the draft Guideline on the Development and Manufacture of Synthetic peptides. In addition to the current lack of specific guidelines, EMA cited increased industry interest in developing peptide medicines as a motivation for developing the proposed guidelines. At SciencePharma we are always up to date […]
The Windsor Framework: MHRA to Take Full Control of Medicines Regulation in Northern Ireland
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 […]
Public consultation on ICH E6(R3) Guideline on good clinical practice (GCP)
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.
CEP 2.0 as new certification form issued by EDQM for demonstrating substance used in the preparation of medicinal products compliance with the European Pharmacopoeia
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
RAPS: New FDA Warning Letters Highlight CGMP Deviations at API Plants in China, India
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: Regulatory cooperation to improve global health
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 […]
EMA: Release of documents on two medicines temporarily halted
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 […]
FDA: Hypertension Indication: Drug Labeling for Cardiovascular
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 […]
MHRA: MHRA’s Interpretation of Cross Contamination & PDEs
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