zhulikou431October 11, 2018
Tag: EU , ICH , PV Regulations
EU
The EU has been early in conducting PV, and possesses a sound PV system which is also divided into three layers for regulation: directives, regulations, and guidelines. See the following table for the main establishment process of regulations of the EU PV system.
Table 1 Main Regulation Documents within Legal Framework of the EU PV System
Name |
Type |
Release time |
Released by |
Main content |
2001/83/EC |
Directive |
November 6, 2001 |
European Parliament (EP), Council of the European Union |
Chapter 9 details the content of PV |
726/2004/EC |
Regulation |
March 31, 2004 |
EP, Council of the European Union |
It lays down procedures for management of pharmaceutical product marketing approval and monitoring |
2004/27/EC |
Directive |
March 31, 2004 |
EP, Council of the European Union |
It raises higher requirements for the quality, safety, and effectiveness of pharmaceutical products for human use |
EudraLex: Pharmacovigilance guidance for human medicinal products (Volume 9A) |
Guideline |
March 2007 |
European Commission (EC) |
It laid down detailed provisions of the PV of the EU and was subsequently replaced by the good pharmacovigilance practice (GVP) |
1235/2010/EU |
Regulation |
December 15, 2010 |
EP, Council of the European Union |
It strengthens the safety monitoring of pharmaceutical products after marketing, and improves the risk-benefit balance of pharmaceutical products |
2010/84/EU |
Directive |
December 15, 2010 |
EP, Council of the European Union |
It strengthens the safety monitoring of pharmaceutical products after marketing, and improves the risk-benefit balance of pharmaceutical products |
520/2012/EU |
Regulation |
June 19, 2012 |
EC |
It is the detailed rules for the implementation of the Regulation 1235/2010/EU and Directive 2010/84/EU |
1027/2012/EU |
Regulation |
October 25, 2012 |
EP, Council of the European Union |
It revises insufficiencies in the Regulation 1235/2010/EU |
2012/26/EU |
Directive |
October 25, 2012 |
EP, Council of the European Union |
It revises insufficiencies in the Directive 2010/84/EU |
EU Guideline on good pharmacovigilance practices (GVP) |
Guideline |
2012-2013 |
EMA |
It consists of 16 modules, with each module corresponding to a major PV process |
EMA plays a key role in pharmaceutical product approval and supervision in the EU PV system; its responsibilities are mainly to coordinate the PV work of EU, including establishing and maintaining EudraVigilance database, establishing periodic safety update report (PSUR) repository, establishing and maintaining EMA portal website, setting the format for electronic submission of pharmaceutical product information, regularly reviewing PV activities, assessing risk management system, and cooperating with WHO, etc. Furthermore, marketing authorisation holders (MAHs) are responsible for guaranteeing the safety of pharmaceutical products throughout the life cycle, and drug regulators of member states of EU are responsible for inspecting premises, records, and PV master files of MAHs.
Currently, the basic norms for the EU PV implementation are EU Guideline on good pharmacovigilance practices (GVP) which includes 16 modules: Pharmacovigilance systems and their quality systems, Pharmacovigilance system master file, Pharmacovigilance inspections, Risk management systems, Collection, management and submission of reports of suspected adverse reactions to medicinal products, Periodic safety update report (PSUR), Post-authorisation safety studies (PASS), Signal management, Additional monitoring, Public participation in pharmacovigilance, Safety communication, Risk-minimisation measures: selection of tools and effectiveness indicators, and International cooperation, etc. The new EU PV system established through the said guideline has basically covered the entire life cycle of pharmaceutical product, and established stronger relationships between pharmaceutical product safety assessment and regulation actions.
Related:
Overview of EU and U.S. PV Regulations and PV Regulation Trend after China Joined ICH--U.S.
Overview of EU and U.S. PV Regulations and PV Regulation Trend after China Joined ICH--China
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