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In continuation of our series of interviews, Sam Vakili, Founder & CEO, INVEST.IN.TEK shared with me his views on the impact of European regulatory policy on Biotech investments in Europe.

Regulatory policies and frameworks indeed play a critical role in shaping the investment environment for biotech companies. In Europe, regulatory guidelines aim to balance ensuring patient safety, maintaining high scientific standards, and fostering innovation in the biotech sector. European regulatory policies support biotech investments by providing a transparent and predictable product development and commercialization pathway. The European Medicines Agency (EMA) is the central regulatory authority responsible for evaluating and approving medicines in the European Union (EU). The EMA follows a robust scientific evaluation process, including assessing biotech products' quality, safety, and efficacy before granting marketing authorization. The European regulatory landscape also offers various mechanisms to support biotech companies. For example, the EU provides expedited regulatory pathways, such as the Priority Medicines (PRIME) scheme and the Accelerated Assessment procedure, to facilitate developing and approving innovative therapies addressing unmet medical needs. These programs aim to streamline regulatory processes and provide early access to promising treatments. In addition to the EMA, individual European countries have regulatory agencies that oversee biotech products nationally. Harmonization efforts, such as the Mutual Recognition Procedure and the Decentralized Procedure, enable companies to seek simultaneous approvals in multiple European countries, reducing duplication of efforts and regulatory burden. One significant development is the implementation of the new EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). These regulations aim to strengthen the oversight and safety of medical devices and in vitro diagnostics, including certain biotech products. Compliance with these new regulations has required biotech companies to invest additional resources and undergo a rigorous assessment process, impacting their timelines and financial considerations. Moreover, the emergence of novel therapies, such as gene therapies and cell-based immunotherapies, has prompted regulatory adaptations in Europe. Regulatory agencies have been working to establish clear guidelines and frameworks for evaluating these innovative treatments. For example, the EMA has published specific guidelines on developing and evaluating advanced therapy medicinal products (ATMPs), providing clarity for biotech companies operating in this space and facilitating investment decisions. Overall, European regulatory policies strive to support biotech investments by providing a predictable and transparent framework for product development and commercialization. Recent regulatory actions, such as the implementation of the MDR and IVDR, and the establishment of guidelines for advanced therapies, have notably impacted investment decisions by influencing timelines, resource allocation, and compliance requirements for biotech companies operating in Europe. Biotech companies and investors must monitor regulatory developments to navigate the evolving landscape effectively and closely.

Sam Vakili will be presenting on Navigating the Financing Landscape in Biotech: Strategies for Securing Investment at Different Stages of Drug Development/ Clinical Trials at COG Europe, taking place on the 10th & 11th October 2023, in Milan, Italy. More information can be found here:

INVEST.IN.TEK GmbH is a Hamburg-based advisory boutique. With over a decade of experience, they've built a professional bridge between Europe and the APAC region, including a strong footprint in DACH, Benelux, Nordics, China, Singapore, Hong Kong, India, and South Korea. With a network of 20+ market and industry experts, along with our experienced growth advisors and venture capitalists, can help you structure, accelerate, and scale. INVEST.IN.TEK GmbH offer hands-on help and strategic guidance in go-to-market, soft-landing, talent acquisition, and fundraising. We take the time to educate founders on potential markets, help develop customized go-to-market strategies, and assist in achieving targets.

** Disclaimer: the views shared here are the author’s alone, and not of the Pharmaceutical Business Conference Group, INVEST.IN.TEK or any other organisations mentioned **


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