Role of SMEs in Pharma

Are small and medium enterprises (SME’s) really a major driver of innovation in the pharmaceutical industry?

As we cross the 15th anniversary of the adoption of the European Medicines Agency SME Regulation that promotes innovation and the development of new medicines in Europe, we’re seeing more marketing authorization applications from this sector of the industry than ever before.

In just the last 5 years the success rate of marketing authorization applications for human medicines submitted by SMEs to the EMA has more than doubled. From a 40% positive opinion rate in 2016, up to a staggering 89% in 2020.

In 2020 alone SMEs were credited with 16 recommendations for approval of new medicines, and since the creation of the SME Office in 2005, more than 130 medicines developed by SMEs have been approved following an EMA recommendation.

Covering both the human and veterinary areas, the ability for smaller firms to contribute significantly is clear to see, and with half the human submissions in the past five years targeting rare diseases, the answer is an astounding yes, SME’s really are a major driver in the pharma industry.

If you’re the next SME looking for EMA approval for your #medicine, speak to the QUINTA-ANALYTICA team today. With an A-Z of services spanning the whole pharmaceutical spectrum, Quinta possesses unrivaled expertise across analytical services, in-house clinical studies, and much more.