GMP News - Regulatory Affairs

Due to inquiries concerning the handling of ICRs in EudraVigilance, the EMA has published a brief and structured clarification.

The UK Government has released some information regarding the consequences of the Brexit on pharmacovigilance and the establishment of the Qualified Person for Pharmacovigilance (QPPV).

The UK Government has released advice regarding the consequences of the Brexit on clinical trials.

The final FDA guidance provides recommendations regarding the required documentation related to the control of elemental impurities consistent with ICH Q3D and USP General Chapters <232> and <233>. Read more about FDA´s guidance on Elemental Impurities in Drug Products, which applies to manufacturers of noncompendial and compendial drug products.

The EMA published information extracted from the Article 57 database (xEVMPD) in the form of an Excel document. The file contains a complete list of all medicines authorized in the EEA with marketing authorization holders' dedicated contact details for pharmacovigilance enquiries.

With the final guidance on the Use of Electronic Health Record Data in Clinical Investigations the US FDA intends to assist sponsors, clinical investigators, contract research organizations (CRO´s), institutional review boards (IRBs), and other interested parties in the use of eHR data in clinical investigations.

The European Medicines Agency (EMA) has  published a press release and announced the next phase of its business continuity plan. According to this release the Agency will need to further scale back and suspend activities.