The European Medicines Agency (“EMA”) has updated its guidance (Guidance) regarding procedural advice for medicinal products intended exclusively for markets outside the European Union (“EU”). The Guidance addresses several questions which applicants requesting a scientific opinion as provided in Article 58 of Regulation (EC) No 726/2004 (“Article 58”, the “EMA Regulation”) may have. Article 58 of the EMA Regulation provides that EMA, in co-operation with the Word Health Organisation (WHO), may provide a scientific opinion concerning certain medicinal products for human use. These medicinal products are intended exclusively for markets outside the EU in which population is largely low and middle income.

The Guidance also provides information regarding issues that are commonly discussed during pre-submission meetings related to requests for scientific opinions. Pre-submission meetings provide applicants with the opportunity to obtain regulatory and procedural advice regarding their application in accordance with Article 58 of EMA Regulation. Accordingly, EMA explicitly encourages the establishment of pre-submission meetings with the applicants concerning the evaluation of medicinal products that are intended for non-EU markets.