The agency published an action plan to nurture innovation and drug development by SMEs.
On May 31, 2017, the European Medicines Agency (EMA) announced an action plan to help small and medium-sized enterprises (SMEs) develop novel human and veterinary medicines. The plan is based on the experience of the EMA’s SME Office and will provide training and other support to SMEs.
Specifically, the plan will include spreading awareness of the agency’s initiative by engagement with pharmaceutical players including incubators, universities, and investors. It will offer training that includes an expanded EU Network Training Center. It also supports action to maximize the use of regulatory tools for the development of treatments for unmet needs. The plan will also foster the development of the EU Innovation Network, SME support initiatives, and additional support for SMEs in regards to funding and administration. According to EMA, SMEs make up 99% of all businesses in the European Union and play an important role in the development of new drugs.
More on EMA’s SME initiatives can be found in the SME Office’s annual report.
Source: EMA
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
AES Clean Technology Launches Next-Generation OSM Utility Solution for Cleanrooms at INTERPHEX 2025
April 2nd 2025Officially launched at INTERPHEX 2025, the Omni ASCENT is a next-generation off-site manufactured vertical utility solution that offers optimized cleanroom flexibility and efficiency.