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 f... Read More
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