Posted on 03 May 2018

Regulatory News - May 2018

Brexit: Redistribution of UK’s portfolio of centrally authorised products (EMA news).

The EMA has released the updated Important Medical Event (IME) list in MedDRA version 21.0. The link is available here.

The EMA has set up an inventory of patient registries in the resources database of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP).

The EMA has issued the European Union recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from autumn 2018.

The EMA has released for public consultation a draft addendum to the guideline on the evaluation of medicinal products indicated for the treatment of bacterial infections to address paediatric-specific clinical data requirements - First version. This addendum to the Guideline has been developed to provide specific guidance on paediatric clinical development programmes that are required to support the authorisation of antibacterial agents for the treatment of infectious diseases in paediatric patients.

The Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) has endorsed new measures to avoid exposure of babies to valproate medicines in the womb because exposed babies are at high risk of malformations and developmental problems. The communication in full is available by clicking here and includes information to patients and healthcare professionals.

The US FDA issued draft guidance on Scientific and Ethical Considerations in Including Pregnant Women in Clinical Trials.

The US FDA issued guidance on how to comply with the final rule on post-marketing safety reporting requirements for combination products (issues on 20 Dec 2016; 81 FR 92603).

A new CIOMS group has been established: New working Group XI - Patient Involvement in Development and Safe Use of Medicines. The task for the CIOMS group would be to develop criteria and guidelines on patient involvement in drug development, pharmacovigilance and risk management as well as several other areas where harmonised and pragmatic patient-centred approaches should be adopted.