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EMA publishes marketing application guidance for pharma

Aims to clarify what to include in summaries of product characteristics

Pharma companies submitting marketing applications for new medicines to European regulators will now have guidance on what to include in the summary of product characteristics (SmPC).

The European Medicines Agency has published several presentations on what to include in each section of the SmPC, which contains such information as how a medicine should be used, its associated benefits and risks and its potential effects in such groups as children or people using other medicines.

In total, the EMA has provided 23 downloadable PDFs, which take applicants through each individual section of the SmPC, as well as further information for generics, hybrids and biosimilars.

There is also a presentation about why SmPCs are a necessary part of the drug approval process and specific information about SmPCs in relation to older people, children and pharmacogenomics (drugs that affect DNA or RNA).

In addition, the EMA has also created three videos: one offering background information about SmPCs (see below) and two explaining in detail specific sections of the process, namely 'undesirable effects' and 'therapeutic indications and pharmacodynamic properties'.

“[The guidance] is intended to enable companies to make sure that the information in SmPCs is of high quality when they submit them to the Agency as part of applications for new marketing authorisations or updates to existing marketing authorisations,” said the EMA in a statement.

Detailing the importance of ensuring the SmPC is prepared correctly, the EMA's guidance explains that it is the “basis of information for healthcare professionals on how to use the medicine”.

SmPCs are also used in the development of package leaflets, meaning any information contained in the summary could potentially have a direct influence on patients.

The Agency also reiterated that SmPCs should be kept updated throughout the lifecycle of a medicine as new efficacy or safety data emerge.

• Read the EMA's guidance on SmPCs

23rd January 2013

From: Regulatory



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