EMA Introduces New Fee Incentives for SMEs

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 04-01-2014 20:10


The European Medicines Agency has introduced new fee incentives to support micro, small and medium-sized enterprises (SMEs) developing medicines for human and veterinary use. The new incentives apply to post-authorization activities. They include total or partial fee exemptions for the following activities:

  • Extension of a marketing authorisation;
  • Type-IA, type-IB or type-II variation;
  • Renewal of a marketing authorisation;
  • Transfer of marketing authoris\zation between two SMEs;
  • Referral procedure initiated by the marketing-authorization holder as laid down in Article 30(1) or the first sub-paragraph of Article 31(1) of Directive 2001/83/EC;
  • Post-authorization annual fee.

Micro-sized enterprises benefit from a 100% fee reduction while small and medium-sized enterprises have a 40% reduction of the total applicable fee.

The Agency sais it took this initiative in response to concerns raised by SMEs about the burden of fees for post-authorization procedures for small businesses.

These new fee exemptions complement the incentives that are already available to SMEs, particularly during the pre-authorization and marketing authorization phases. They are intended to reinforce support and encourage innovation throughout a medicine’s lifecycle in the interest of public and animal health.

SMEs are a major driver of innovation in the pharmaceutical industry. A recent analysis conducted by the EMA showed that, between 2010 and 2012, more than 60% of the medicines authorised for the treatment of a rare disease in the European Union (EU) originated from SMEs. In addition, three out of the four advanced therapy medicines approved in the EU so far are from SMEs.

Recognizing the role of SMEs in the development of innovative medicines, the agency has a program in place to support them through active regulatory, financial, and administrative support. The support takes the form of fee reductions for scientific advice throughout the medicine’s lifecycle, more outreach programs through topical workshops, and dedicated newsletters.

There are currently over 1100 SMEs in the Agency’s public SME register of which 44% are micro-sized (fewer than 10 staff members), 39% are small-sized (fewer than 50 staff members) and 17% are medium-sized companies (fewer than 250 staff members).

Source: EMA


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