Recent recommendations on transparency from HMA/EMA

31 January 2011

Teresa Mercadal Menchaca

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) are working together in relation to the release of information with medicinal relevance. The EMA is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union, which were approved via the centralised procedure. The Member States can also refer queries to the EMA when a medicine is being evaluated via the decentralised, or mutual recognition procedure. The HMA is formed by the heads of the National Competent Authorities (NCAs), which are responsible for the regulation of medicinal products for human and veterinary use in the European Economic Area[1].

This EMA/HCA collaboration makes it possible to obtain a harmonised regulation for the European Economic Area, and joint recommendations of on transparency would be useful to facilitate a common approach between NCAs, as well as between the NCAs and the EMA.

Both organisations are striving to achieve transparency on the field of medicines. Transparency is highly important as it implies openness, communication and accountability. However, this is a sensitive field because every disclosure has to respect the protection of both personal data and commercially confidential information.

The last recommendations dictated by HMA/EMA were published on November 2010 (EMA/484118/2010). These recommendations relate to the release of information regarding  to new applications for medicinal products (generics/biosimilars, non-prescription medicinal products and innovative medicinal products), both before and after any opinion or decision on the granting of a marketing authorisation: before an opinion or decision on the granting of a marketing authorisation, the information that can be released is only the therapeutic class and the name of the active substance. In the case of generics, the information to be realised is limited to the active moiety, but not to salts, esters or derivatives.

After an opinion or decision on the granting of a marketing authorisation, the information that can be released is the name of the active substance (including in every case salts, esters or derivatives); the invented name; the name of the applicant; the legal basis; the therapeutic class; the date of submission; the Member States concerned; and other information such as the summary of product characteristics, the product leaflet, the European Public Assessment Report (EPAR) or the Certified Clinical Investigator[2] (CCI).

HMA and EMEA are continuing to work towards further recommendations on transparency.

[1] The HMA group represents a diverse network of 44 National Competent Authorities (NCAs) from the 27 EU Member States and three Member States of the European Economic Area-European Free Trade Association (EEA-EFTA), namely: lceland, Liechtenstein and Norway. Of the 44 NCAs, 13 have responsibility only for human medicines; 13 are purely veterinary agencies; 18 have responsibility for human and veterinary medicines (joint agencies); and some veterinary agencies are integrated with their respective national food safety agencies. Some have responsibility for pricing and reimbursement of human medicines (22 are joint medicines / medical devices agencies), while others are also responsible for anti-counterfeiting work, the regulation of medical devices, blood products, cosmetics, biocides, novel foods, and herbal medicines.

[2]A clinical investigator who meets required experience and educational levels and has earned certification by passing an exam.