This article is more than 5 years old. Information may no longer be current.
European Union moves closer to adopting new drug approval plan
If agreed upon, the new regulation system could be implemented in 2004.
Click Here to Manage Email Alerts
Legislation that would establish a new system of registering and approving pharmaceuticals marketed in the European Union could be finalized as early as the end of the year.
The proposed plan calls for mandatory centralized registration of certain medicines at the London-based European Agency for the Evaluation of Medicinal Products (EMEA), including those used to treat human immunodeficiency virus/AIDS, diabetes, neurodegenerative diseases and cancer. Manufacturers of those drugs that are exempt from mandatory registration would have the option of registering them either through EMEA’s centralized system, which European Union (EU) authorities say would be fastest, or the decentralized process that utilizes national authorities.
The plan being considered was already reviewed once by the EU Parliament prior to June 2, when EU member states met in Luxemberg to discuss it. Both groups need to agree on the plan before it can become law.
“We aim to be as competitive as the U.S. Food and Drug Administration (FDA) and we expect that the centralized procedure will be between nine and 11 months, less than one year,” EU Commission spokesperson Per Haugaard told Orthopaedics Today in a telephone interview.
Other drugs could be added
Other drugs could still be added to those already slated for mandatory centralized registration, depending on what occurs at the Parliament level. For example, member states discussed adding obesity management drugs to the list, but the idea was dropped. “We are in favor of expanding the scope as much as possible because we feel that this … would be the most efficient and speedy solution for industry and consumers,” he said.
Under the decentralized process, a drug approved by a single EU country using processes currently in place would have to be approved separately by the governments of other member states, although the governments should recognize the initial approval, Haugaard said.
Parliament next has to revisit the entire issue before the EU’s Employment, Social Policy, Health and Consumer Affairs Council or member states can make the proposal into law. “Those two institutions are not very far from each other, so it looks as if what we saw coming out of the member states [during the June meeting in Luxemburg] will probably be pretty close to the final result,” Haugaard said.
Other issues decided on at the EU government meeting concerned 10-year data protection for drugs authorized under the mandatory centralized procedure, with an additional one year of protection if product developers can identify a new indication for the drug. Data protection currently ranges from six to 10 years and varies by country.
Generic versions
Also according to the proposed legislation, manufacturers wishing to apply for marketing approval for generic versions of drugs approved under the decentralized process or the optional centralized process could do so two years before the 10-year data protection period expires.
Once approved, the new procedures would become law immediately, but before the entire legislation is put into place, officials will need to implement a separate corresponding human drug directive in all the member states, a process that could take 15 to 18 months. “We are probably looking at the middle or latter part of next year before the whole package will enter into force,” Haugaard said.
The centralized drug program will be similar to the U.S. FDA and “will involve scientific experts from throughout Europe who will work hard to ensure that the scientific quality of the authorizations are at the top level,” he said.