Medical Device Coordination Group Document MDCG 2021-3

The Medical Device Coordination Group (MDCG) provides advice to the Commission and assists the Commission and the Member States in ensuring a harmonised implementation of medical devices Regulations (EU) 2017/745 and 2017/746. “Questions and Answers on Custom-Made Devices & considerations on Adaptable medical devices and Patient-matched medical devices” is a high-level document aimed at addressing the most pertinent questions relating to custom-made devices falling under Regulation (EU) 2017/745 on medical devices (MDR).
March 26, 2021

General chapter 2.5.42. N-Nitrosamines in active substances and revised sartan monographs

In February 2021, the European Pharmacopoeia revised 5 monographs on sartans containing a tetrazole ring [(Valsartan (2423), Losartan potassium (2232), Irbesartan (2465), Candesartan cilexetil (2573) and Olmesartan medoxomil (2600)]. The rapid revision process concerned a new wording of the “Production” section and the deletion of the N-nitrosamines test section. The 5 revised monographs will become legally binding on 1 April 2021.
March 26, 2021

Nitrosamine Risk Evaluation

The first deadline is approaching (March 31, 2021 for chemical medicines), make sure your company is meeting compliance standards. Choose Pharma D&S as service provider! #nitrosamine #riskevaluation #pharmadesgroup
March 25, 2021

Q&A: Good clinical practice (GCP)

EMA published a guidance in forms of Questions and Answers on good clinical practices. (GCP). Table of contents are:

  • Investigational medicinal products (IMPs) in bioavailability and bioequivalence trials
  • GCP matters
  • Expectations of European Union (EU) competent authorities on the use of electronic trial master files
  • Records of study subject data relating to clinical trials

February 25, 2021