HERA MUST ADDRESS OUTSTANDING WEAKNESSES IN EU PHARMA FRAMEWORK TO BE SUCCESSFUL
Medical Information and Communications Conference
Virtual event | 13.10.21 - 15.10.21
10th Strategic Conference Value of Innovation
Virtual event | 07.10.21
EFPIA Newsletter 16 September 2021
HERA: Putting Europe on the front foot against global health threats
The Porto European Cancer Research Summit 2021
Can Europe make the impossible, possible?
Blog of the MHRA on Transfer of Analytical Methods
The regulatory authority of the United Kingdom, the MHRA (Medicines and Healthcare products Regulatory Agency), regularly provides information on GMP-relevant topics in a blog on its website.
EDQM updates Guidance for Electronic Submission of CEP Applications
In July 2021, the EDQM (European Directorate for the Quality of Medicines & HealthCare) renewed the document "Guidance for electronic submissions for Certificates of Suitability (CEP) applications" and published it on the corresponding website on 01 September 2021. This document provides some explanatory guidance and information on the electronic submission of "CEPs" (Certificate of Suitability of Monographs of the European Pharmacopoeia).
New FDA Draft Guidance for Industry on Bioequivalence Studies
In August 2021, the U.S. Food and Drug Administration (FDA) has announced the availability of a draft guidance for industry entitled “Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA.” The guidance document was published on the FDA's website for comment purposes only. Comments and suggestions should be submitted within 60 days.
FDA´s final Q&As on Field Alert Reports
FDA Warning Letter on Significant Data Integrity Issues at Chinese Manufacturer
Data integrity issues continue to be a focus of FDA inspections. Significant problems with data proving the safety, efficacy and quality of manufactured medicinal products were among the reasons for the Warning Letter to the Chinese company BBC Group Limited.
Final EMA Guideline: Quality Requirements for Combination Products
Following a draft version, the EMA has now published the final guideline, which describes what documentation is required on the subject of quality for combination products in order to gain and/or maintain a marketing authorization. The guideline consists of 22 pages with 10 chapters.
2 new Ph. Eur. reference standards and 15 replacement batches released in August 2021
The European Directorate for the Quality of Medicines & HealthCare (EDQM) announces the availability of 2 new European Pharmacopoeia (Ph. Eur.) reference standards and 15 replacement batches for Ph. Eur. reference standards.
Referrals document: Nitrosamines EMEA-H-A5(3)-1490 - Questions and answers for marketing authorisation holders / applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products (updated)
10. Which limits apply for nitrosamines in medicinal products? (UPDATED)
Template or form: Step 2 - Nitrosamine detected response template (updated)
Clinical pharmacology and pharmacokinetics: questions and answers (updated)
Minutes: Minutes of the PRAC meeting 11-14 January 2021
List of European Union reference dates and frequency of submission of periodic safety update reports (PSURs) (updated)
Notifying a change of marketing status (updated)
Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure - track changes (updated)
FDA In Brief: FDA Posts an Initial Batch of Four Deemed Final Administrative Orders for Over-the-Counter Drugs
(no new develpoments)
CMDH PRESS RELEASES 2021 Report from the meeting held on 14-16 September 2021
Report of 2021 Implementation Survey available now on the ICH website
Sistema de Preços de Referência - 4.º trimestre de 2021
A lista dos Grupos Homogéneos e dos preços de referência unitários a vigorar no 4.º trimestre de 2021 foi aprovada e entra em vigor a 1 de outubro de 2021.
Portaria n.º 200/2021171672326
Define o regime excecional de comparticipação no preço das vacinas pneumocócicas
PGEU toma posição no processo de vacinação da gripe por farmacêuticos
Glyphosate: EFSA and ECHA launch consultations
Proibição do aditivo Dióxido de Titânio (E 171)_Proposta de regulamento publicada (ver anexo)
Desafios Genéricos da Saúde (APOGEN)