GMP DATABASE
EMEA Launches GMP Database
London (May 1)—The European Medicines Agency (EMEA,
http://www.emea.europa.eu/) launched a database designed to facilitate the exchange of information about compliance with good manufacturing practices
(GMPs).
EMEA designed and launched the database, called EudraGMP, to improve national competent authorities' ability to supervise
the quality of medicines. It contains information about all manufacturing and importation authorizations issued by national
authorities of individual European Union (EU) member states as well as Liechtenstein and Norway. The database also contains
information about GMP certificates, which the competent authorities issue following each GMP inspection conducted either within
the network or in third countries.
EMEA expects that EudraGMP will improve the sharing of information and the coordination of action for manufacturing authorizations
and GMP certificates between national authorities by eliminating duplication. The database also facilitates information sharing
about the outcome of EU inspections with regulatory authorities outside Europe.
Only national competent authorities, the European Commission, and EMEA can access the database. National competent authorities
worked closely with EMEA to design the database as part of the EU telematics strategy for pharmaceuticals. The strategy was
agreed upon by EU member states, the European Commission, and EMEA in 2000.
Approximately 15,000 importers and manufacturers operate in Europe, and EMEA expects that as many as 7000 potential new GMP
certificates will be included in the database each year. These numbers are expected to increase as third-country inspections
begin and new GMP requirements for active substances are implemented.
-Angie Drakulich
VACCINE SUPPLY
New Hope for Worldwide Influenza Vaccine Supply
Geneva, Switzerland (Apr. 27)—A meeting of the World Health Organization (WHO,
http://www.who.int/) and the Committee for Medicinal Products for Human Use's (London,
http://www.emea.eu.int/) approval of Novartis's (Basel, Switzerland,
http://www.novartis.com/) new cell culture-derived influenza vaccine offered new hope that sufficient numbers of vaccines could be produced in case
of a pandemic.
Increasing vaccine production capacity has been a concern for WHO since it was determined during a two-day meeting in February
2007 that the industry lacked "the manufacturing capacity to meet potential pandemic influenza vaccine demand."
At a meeting at WHO headquarters on April 25, representatives from countries that have experienced human H5N1 infections,
donor countries, and vaccine manufacturers agreed to develop a mechanism to ensure that developing countries have access to
influenza vaccines in case of a pandemic. Attendees also discussed the possibility of creating a stockpile of H5N1 vaccine
and concluded that it "may be feasible" as vaccine manufacturers increase capacity over the next three to five years to meet
growing demand.
WHO plans to set up expert groups to explore the best way to create, maintain, fund, and use a stockpile of Avian influenza
vaccine. However, Marie-Paule Kieny, the director of the WHO initiative for vaccine research, admitted that presently "most
countries with resource constraints do not have the means to access influenza vaccines." To address this issue, WHO is supporting
an effort to build production facilities in developing and industrialized countries. This effort has received financial support
from the Japanese government and from the United States Department of Health and Human Services (HHS, Washington, DC,
http://www.hhs.gov/). Projects to establish influenza vaccine manufacturing facilities are in the final stages of approval in two Latin American
and four Asian countries.
|
