EMEA reforms to speed drug approval
pharmafile | October 13, 2005 | News story | Sales and Marketing |
Europe's medicines regulator is looking to communicate more effectively with pharma companies as part of a drive to accelerate drug approval times.
The EMEA provides the industry with scientific advice during the appraisal of a new drug application, but the regulator is looking to make this process faster and more consistent.
A spokesperson for the EMEA said: "We hope these changes will help pharmaceutical companies to develop their products faster so patients gain better and faster access to these medicines – that's our ultimate aim."
The regulator is consulting with stakeholders on how to cut the time it takes to finalise scientific advice, and is proposing more staff for its expert panel the Scientific Advice Working Party.
The EMEA wants earlier and greater involvement of its own scientists as well as external experts and believes earlier collaboration will help it complete assessments within 40 or, at the most, 70 days rather than the current 100-day deadline.
A peer review by the CHMP will also be introduced before final advice is issued to make sure the advice is as clear and consistent as possible.
The EMEA also wants to improve the transparency of the scientific advice process and increase communication with stakeholders such as patient groups and academia.
The Working Party was given a stronger role when the EMEA's role was enlarged in May 2004.
It provides advice on a broad range of highly specialised topics including preclinical safety, pharmacokinetics, statistics and therapeutic fields for which there are frequent requests (eg, cardiology).
Nearly two years ago, Europe's politicians agreed the EMEA should take on a greater role in the newly enlarged EU, but one of the biggest changes is yet to come into force.
From November, a new mandatory centralised procedure comes into effect, meaning any new products for AIDS, cancer, neurodegenerative disorders and diabetes will be fast-tracked through the EMEA.
The agency's 'centralised procedure' means once a drug is approved by the EMEA, it is approved in all member states simultaneously, in contrast to 'mutual recognition' where one country takes a lead.
This mandatory list will be expanded in May 2008 to encompass auto-immune diseases and other immune dysfunctions and viral diseases, a move that is hoped will get innovative new treatments to patients faster.
External links:
New Framework for Scientific Advice & Protocol Assistance:
www.emea.eu.int/pdfs/human/sciadvice/26718705en.pdf
