EMA revises active substance guidelines to streamline regs

By Nick Taylor

- Last updated on GMT

Related tags European union Ema

EMA revises active substance guidelines to streamline regs
The EMA has revised guidelines on active substance master files (ASMF) to stop multiple EU nations assessing the same documents.

In 2005 the European Medicines Agency (EMA) published draft guidelines for ASMFs​, formerly known as European drug master files (EDMFs). An official consultation period ended in 2006 but discussions continued and last year a working group was formed to improve the document.

The long term objective of these administrative amendments is to have a unique version of an ASMF for one active substance valid for the whole European Economic Area (EEA)​”, the EMA wrote in new draft guidelines​.

Currently each ASMF can be assessed by multiple member states, “which can result in duplication of work, inefficient use of assessor resources, and inconsistent decisions being made on the same data​”, the EMA working group wrote​.

In the revised draft the EMA has added an annex and revised other areas to move closer to its long term goal. To achieve this aim the EMA has changed the wording of its template ‘letter of access’ for ASMFs.

The new wording allows all EEA nations, the EMA and its experts, and the Certification of Substances Division of the European Directorate for the Quality of Medicines & Healthcare to share ASMFs between themselves.

As well as changing the annexes the EMA made some alterations to the main body of the guidelines. However, the changes are only “administrative amendments​”, the EMA wrote, and a lengthy consultation period was deemed unnecessary.

The publication of a concept paper was not considered necessary since this revision has mainly an administrative character and stakeholders were already consulted earlier. For the same reasons, a consultation period of two months was considered reasonable​”, the EMA wrote.

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