Strategy Papers · Archiv

HMA Strategy Paper II (2010)

The European Heads of Medicines Agencies (HMA) group devloped a second HMA strategy document for the period 2011-2015, which was finalised and published at the end of 2010. As part of the strategy developemnt process, and in line with good practice, the HMA consulted with key stakeholder groups on the strategy's content.

HMA Strategy Paper 2010 | pdf

HMA Strategy Paper I (2006)

Developing the Heads of Medicines Agencies Strategy for the European Medicines Regulatory Network

HMA (Joint Human and Veterinary) formally adopted the HMA Strategy Paper on European Medicines Regulator Network (ERMN), which was drafted by the UK Presidency on behalf of the HMA. The HMA (Joint) agreed to the formation of an Implementation Group, which Jean Marimbert, Director General of the French medicines agency (AfSSAPS) agreed to chair along with members from 6 other member states. The group will be responsible for taking forward the work set out in the Strategy Paper.

The outcome of the consultation of the HMA Strategy Paper with partners and stakeholders was adopted at the November HMA meeting in Helsinki. With its publication the first consultation cycle of the HMA Strategy Paper is closed and HMA will define the appropriate mechanisms to start working on the next version of the HMA Strategy Paper taking into account the contributions of Partners and Stakeholders, whilst already implementing its main orientations.

(Information added December 2006)

Follow up activities

• HMA Strategy Implementation Group (SIG) - Recommendations on consultation and responses (May 2007)| pdf

• HMA Strategy Paper work plan (latest update: February 2007) | pdf

• Outcome of the HMA Strategy Paper consultation (November 2006) | pdf

• Meeting with Partners and Stakeholders - Summary Report (October 2006) | pdf

• Consultation with HMA Partners and Stakeholders: introductory note and questionnaire (March 2006) | pdf

Strategy Paper - INDEX

• Section 1: Explanatory Note | pdf
• Section 2: HMA Strategy Paper I (Revision Nov 2007) | pdf
• Section 3: Communication and Information | pdf
     3.1 Stakeholders | pdf
     3.2 Defining communication roles Competent Authorities | pdf
     3.3 Legal environment | pdf
     3.4 Daily life communication vs. crisis communication | pdf
     3.5 Solutions and actions | pdf
• Section 4: Scientific resources | pdf
• Section 5: Scientific Assessment Process - New products and referrals | pdf
• Section 6: Pharmacovigilance | pdf
• Section 7: Inspection, laboratory control and enforcement | pdf
• Section 8: IT information systems | pdf

(Information added December 2006)