Korea FDA Moving To Strengthen Pharmacovigilance - APEC Harmonization Center Asia Regulatory Conference

SEOUL - Korea FDA said it is planning to introduce a set of pharmacovigilance-related policies including the establishment of a national drug safety management center to collect, assess, evaluate and disseminate drug safety information.

Speaking to attendees at the APEC Harmonization Center's Asia Regulatory Conference in Seoul on April 28, Oh Joung-won, deputy director of KFDA's Pharmaceutical Safety Bureau said the safety management center will operate an adverse drug reaction reporting system alongside drug utilization reviews to assess causality of adverse drug reactions.

"We hope to launch the center sometime this year after revision of a related drug law at the National Assembly," Oh said in an interview along the sidelines of the conference. "A draft law has been passed to the National Assembly, thus we expect to see the revision, hopefully in May."

Oh expects the center to oversee drug safety-related issues, including a major expansion of DURs within five years and the release of periodic drug safety updates

The center will assess causality of adverse drugs reactions as part of KFDA's effort to protect patients as well as minimize medical expenses, Oh said, referring to the widening deficit the South Korean government carries as a result of the country's mandatory national medical insurance system.

Korea's Ministry of Health and Welfare has been seeking ways to cut prices of drugs covered by national medical insurance to make up for losses in the national medical insurance scheme (Also see "Effects Of Korea's New Drug-Pricing System Still Murky" - Scrip, 25 Jan, 2011.).

KFDA's vision is to have in place by 2020 a "Life-Cycle Drug Approval and Pharmacovigilance System," which would enable KFDA to conduct DURs both before and after approval.

Electronic Pharmacovigilance Next Steps

A national pharmacovigilance system will integrate an electronic management system in cooperation with the Korea Drug Safety Management Center, local pharmacovigilance centers, public health institutions and government hospitals, Oh said.

The electronic pharmacovigilance system and database would be shared with public and private hospitals, but this is a long-term plan and there is no concrete schedule at this point, according to Oh. In addition, a compensation system for patients who suffer adverse drug reactions could also be included.

As part of the drug safety program, KFDA is also planning to introduce a Risk Evaluation and Mitigation Strategy system by the end of this year as part of efforts to minimize post-approval risks by evaluating anticipated risks before approval.

U.S. FDA established a similar REMS system in 2007, although the system is still under refinement. For instance, the agency wants more authority to mandate risk management across a drug class. Also, if FDA decides a REMS is needed after a product is on the market, the agency does not have much leverage to impose the type of risk management it wants (Also see "The REMS Filibuster: FDA Wants Ability To End Post-Approval Talks, Make Final Decision" - Pink Sheet, 20 Dec, 2010.)).

KFDA's Oh said the agency is also aiming to be more involved with International Conference on Harmonization activities as more regulatory agencies in Asia Pacific are adopting variations of ICH guidelines for their own countries (Also see "Voices From Emerging Markets Expected At Next ICH Steering Committee - APEC Harmonization Center Regulatory Conference" - Scrip, 27 Apr, 2011.).

KFDA is also moving toward adopting international good manufacturing practices standards, Oh said. Some top Korean pharma companies such as LG Life Sciences, Celltrion and Yuhan already meet U.S. GMPs, while others are in the process of upgrading facilities to be able to market their products in the U.S. However, smaller Korean drug firms are unlikely to adopt higher standards because upgrading facilities would be too costly for them, according to analysts.

The direction of KFDA's pharma policy is taking its lead from the U.S. and EU, Oh said, with KFDA following the EU model for approval and registration of biosimilar products (Also see "Korea FDA Unveils Initial Biosimilar Guidance; Final Guidelines To Be Released In July" - Scrip, 29 Jun, 2009.).

- Peter Chang ([email protected])

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