VACCINES
WHO Stresses Lack of Capacity for Pandemic Flu Vaccine
Geneva, Switzerland (Feb. 16)—During a two-day meeting, the World Health Organization (WHO,
http://www.who.int/en/) announced "encouraging progress" in the development of a pandemic influenza vaccine. Nonetheless, with a current capacity
estimated at less than 400 million doses per year of the trivalent seasonal influenza vaccine, WHO emphasized that the industry
still "lacks the manufacturing capacity to meet potential pandemic influenza vaccine demand."
Currently, 16 manufacturers from 10 countries are advancing prototype vaccines against the H5N1 virus, and more than 40 clinical
trials have been completed or are ongoing.
Company Notes
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More than 100 influeza-vaccine experts attended the meeting, reviewing information on more than 20 projects involved in H5N1
vaccine development.
As part of its 2006 global influenza action plan, supported by a $10-billion funding by the United States, WHO is working
with several vaccine producers to establish vaccine-production facilities in developing countries.
-Maribel Rios
DRUG APPROVAL
EGA Concerned About Regulatory Workload in Approving Generics
Brussels (Feb. 13)—The European Generic Medicines Association (EGA,
http://www.egagenerics.com/) raised concerns about what it terms "the serious lack" of resources available to member states in the European Union (EU)
to deal with the regulatory workload and bottleneck in new registrations caused by the new Decentralized Procedure (DCP) for
approving drugs in Europe.
While welcoming the DCP, EGA raised issues about delays in the regulatory approval process. "The EGA has welcomed the introduction
of the Decentralized Procedure," said Greg Perry, director general of EGA, who spoke at the 6th Annual EGA Regulatory and
Scientific Affairs Conference in Brussels in mid-February. "It is a great improvement to the marketing authorization process
compared to the older Mutual Recognition Procedure."
The DCP eliminated the first national approval step from the mutual-recognition procedure and the associated delays, said
EGA. This change resulted in fewer "rounds of time-consuming questions, and all the serious questions are raised together
instead of at various times in the process," said EGA.
Roughly 300 generic-medicines applications were filed under the DCP in 2006, according to EGA. In 2006, 70% of the procedures
completed under the DCP (40 out of 57) were for generic products.
EGA said that the generic drug industry is the leading user of DCP, and its use of the procedure will increase as patents
on reference products continue to expire, new member states enter the EU, and the governments of EU member states seek to
increase the use of generic drugs.
To date, only nine of 27 member states have indicated a willingness to act as a Reference Member State (RMS) for applications,
and EGA said it can take as much as one year to receive a confirmation that a member state will act as the RMS.
To address that problem, the EGA proposed an increase in work sharing between agencies in areas such as variations, pharmacovigilance
assessment, reducing the repetition of assessments, and a move to a more harmonized EU approach. EGA also asked companies
to keep agencies better informed of any changes in their plans to submit applications.
-Patricia Van Arnum
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