European Medicines Agency (EMA)

- Based in London, the EMA is the EU competent authority and publishes the guidelines on human and veterinary medicines.

Regulatory approval and market access: a winning combination for drug launch optimization

SCRIP Regulatory Affairs

Having a combined regulatory and market access strategy is critical for a drug launch to be successful.

Patient reported outcomes (PRO)

In market access and payer evaluation of new drugs, patient reported outcomes are as important for payers as are other “quantitative” measures (Biomarker levels in the blood, survival, radiological

EMA HTA Parallel Scientific Advice

When developing a medicinal product, two milestones are of importance for making its path to the market: the granting of a marketing authorization from regulatory agencies and the proof of the medi

European network for Health Technology Assessment (EUnetHTA)

The European network for Health Technology Assessment is a network of government-appointed organizations from European Union Member States, the European Economic Area and accession countries as wel

Core reimbursement dossier

A core reimbursement dossier is submitted during the late stage of development of a product, in order to be considered for reimbursement.


Cost-effectiveness is the ratio of the cost of a therapeutic or preventive intervention to a relevant measure of its effect.

Core value dossier

Core value dossiers are used in the frame of reimbursement negotiations and to support HTA submissions, as well as national and local payers.

Accelerating development, registration and access to medicines for rare diseases in the European Union through adaptive approaches: features and perspectives

Orphanet Journal of Rare Diseases

There is growing recognition that the current research-and-development (R&D) and innovation-regulation ecosystem could be made more efficient to stimulate and support access to innovative therapies for those patients with rare, life-threatening diseases for which there are no adequate licensed therapies.

Building an affordable innovative drug development chain

Express India

Every time there is a new regulation requested by the government, or generated by the industry needs, our scientific and technical contributions not only help us to remain updated but also aware of the philosophy underlying new regulations. Dr Emmanuelle Voisin, CEO, Voisin Consulting spoke on the trends in regulation and how India fits into her plans to build an affordable innovative chain, from discovery to market.