Goodbye to DDPS and Hello to PSMFs

New Pharmacovigilance legislation (Regulation (EU) No 1235/2010 and Directive 2010/84/EU) was adopted by the European Parliament and European Council in December 2010. The aim of the legislation is for better pharmacovigilance and better health protection and promotion.

The legislation is the biggest changes to the regulation of human medicines in EU since 1995. It has significant implications for applicants and holders of EU marketing authorizations. The EMA is responsible for implementing much of the new legislation, effective from July 2012.

Scope of Changes:

1. Authorization requirements: Say goodbye to DDPS (Detail Description of Pharmacovigilance Systems) and hello to PSMFs (Pharmacovigilance System Master File). All MAHs will need to create PSMFs and continuously update them.

2. Risk Management Plans:  All applicants submitting an initial MAA after 2 / 21 July 2012 irrespective of the legal basis of their MA application are required to submit an RMP. This includes generic MA applications.

• For pending initial marketing authorisation applications on 2 / 21 July 2012 which do not contain an RMP, there is no obligation to submit an RMP during the course of the evaluation procedure.
• For those MAs granted before 2 / 21 July 2012 with an existing RMP, the MAH should continue to operate and update the risk management plan.
• As set out in the Commission Implementing Regulation, the new format and content for RMPs shall apply from 10 January 2013 to new or updated RMP submitted as of that date. The template for the RMP will be updated and this is expected to be available around September 2012.
• Marketing authorisation holders (MAHs) are reminded that a summary of the RMP will be published on the European medicines web-portal for the centrally authorised medicinal products and on the national medicines web-portals for the nationally authorised medicinal products. This requirement also applies to existing medicinal products with an RMP.
• Its not required for  a traditional–use registration and homeopathic medicinal products registered via the simplified registration procedure.

3. Post-Authorisation safety studies (PASS) : The new procedures for submission and assessment of non-interventional PASS protocol, substantial amendments and final study results as provided for in Articles 107n to 107q of Directive 2001/83/EC only apply to PASS studies which have been imposed after 2 / 21 July 2012 as a condition to the marketing authorisation. Such studies shall be identified in the RMP. For the CAPs, they will also be incorporated in the Annex II of the marketing authorisation. For the CAPs it means non-interventional PASS imposed through a Commission decision issued after 2 July 2012 including those with an opinion which may have been adopted in the months just before July 2012. For NAPs, it is anticipated that it will be reflected in the national decision to the marketing authorisation.

EMA good pharmacovigilance practice modules for public consultation

EMA releases good pharmacovigilance practice modules for public consultation

The EMA has released the first batch of modules on Good Pharmacovigilance Practices (GVP) for public consultation until 18 april 2012.  

GVP is a set of measures drawn up to facilitate the performance of Pharmacovigilance in the European Union. They apply to marketing-authorization holders, the Agency and medicines regulatory authorities in EU member states and aim to improve safety for patients by strengthening  Pharmacovigilance  across the EU. They cover medicines authorized centrally via the agency as well as medicines authorized at the national level.  

GVP covers following aspects of safety monitoring of medicines. These are:

Module I: Pharmacovigilance systems and their quality systems

Module II: Pharmacovigilance systems master files

Module V: Risk management systems

Module VI: Management and reporting of adverse reactions to medicinal products

Module VII: Periodic safety update reports

Module VIII: Post-authorization safety studies

Module IX: Signal management

The release of these modules is a key deliverable of the 2010 Pharmacovigilance legislation, which will apply from july 2012. Each module was developed by a team consisting of experts from the agency and from EU member states.

The Agency is seeking comments on the practical implementation of the legislation as outlined int these modules. The underlying legal requirements cannot be altered through this consultation process.

Agency intends to finalize and publish these modules by July 2012, after comments from stakeholders have been taken into account.

Reference: EMA releases good pharmacovigilance practice modules for public consultation