EuropaBio welcomes the findings of EMA pilot on parallel scientific advice and new guidance for industry

Date

05 Apr 2016

Sections

Health & Consumers

Press release

Brussels, 5 April 2016 – EuropaBio, the European Association for Bioindustries welcomes the decision by the European Medicines Agency (EMA) to routinely offer parallel scientific advice with Health Technology Assessment (HTA) bodies and other relevant stakeholders as part of its scientific advice activities. The decision comes after the EMA completed its pilot programme on parallel regulatory-health technology assessment scientific advice (see references).

The positive outcomes of the EMA pilot in 2010-2015 confirm the importance of parallel scientific advice for biopharmaceutical companies. In order to accelerate the process of bringing new medicines to patients, it is crucial for companies to be able to obtain advice on how to comply with both regulatory and HTA requirements in one single procedure’, commented Nathalie Moll, EuropaBio’s Secretary General.

In recent years, the complexity and the cost of discovering and developing new biotechnology-derived medicines have constantly increased, making dialogue with the scientific and economic evaluators increasingly important for industry. The proposed advice procedures can help companies to reduce clinical developments timelines and accelerate administrative procedures for the reimbursement of new medications after registration.

Furthermore, the EMA commits ‘to continue to work closely with its stakeholders in the European Union (EU) to refine the model for greater and more robust interaction for parallel advice’. EuropaBio would be pleased to participate in any future EU activities to enhance the procedures for parallel scientific advice, which is a key instrument to support innovation and accelerate patients’ access to treatments. ‘As a way to achieve these ends, EuropaBio would like to encourage further participation of national HTA bodies in these procedures. In particular we would like to call on HTA bodies to allocate adequate resources and expertise to conduct parallel HTA-regulatory scientific advice meetings with developers of healthcare biotech products’, concluded Nathalie Moll. 

ENDS

 

References:

EMA press release, Early dialogue with regulators and HTA bodies, 31 March 2016

Report of the pilot on parallel regulatory-health technology assessment scientific advice

Best practice guidance for the parallel regulatory - Health Technology Assessment Bodies (HTA) scientific advice procedure

 

For media inquiries, please contact:

Cosmin Popa

Communications and National Associations Manager, EuropaBio

c.popa@europabio.org

Telephone: +32 2 739 11 73

Mobile: +32 499 906 129

 

About EuropaBio

EuropaBio, the European Association for Bioindustries, promotes an innovative and dynamic European biotechnology industry. EuropaBio and its members are committed to the socially responsible use of biotechnology to improve quality of life, to prevent, diagnose, treat and cure diseases, to improve the quality and quantity of food and feedstuffs and to move towards a biobased and zero-waste economy. EuropaBio represents 77 corporate and associate members and bio regions, and 16 national biotechnology associations in turn representing over 1800 biotech SMEs. EuropaBio’s Healthcare Council represents both large biopharmaceutical companies and biotech SMEs developing medicines, vaccines and diagnostic tools using biotechnology in their development or manufacturing processes. Read more about our work at www.europabio.org

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