MFDS ‘GMP revocation system reform and ongoing litigation are separate matters’

Announced plan to amend the enforcement rule … to introduce an intermediate GMP suspension measure

AI-generated image

As the Ministry of Food and Drug Safety (MFDS) moves forward with legislative revisions to the GMP certification revocation system in cooperation with the National Assembly, it has clarified that the changes will not apply to pharmaceutical companies that previously had their GMP certifications revoked.

The ministry also drew a clear line regarding companies currently engaged in litigation, stating that the institutional reform is separate from ongoing lawsuits.

According to the MFDS on the 3rd, the proposed amendment to the Pharmaceutical Affairs Act, jointly introduced on the 27th of last month by Rep. Jong-heon Baek (People Power Party) and Rep. Mi-hwa Seo (Democratic Party of Korea), reflects findings from last year’s research on improving the GMP certification revocation system.

The GMP revocation system, implemented in December 2022, is a so-called “one-strike out” rule under which the MFDS revokes GMP certification for manufacturing sites that seriously violate Good Manufacturing Practice standards or repeatedly falsify manufacturing and quality records.

The MFDS revokes GMP certification or changes compliance determinations if they were obtained through ‘false or fraudulent’ means or if manufacturing/quality management records were ‘repeatedly’ falsified or incorrectly documented.

Additionally, it issues a ‘correction order’ if there is a risk of quality impact due to the lack of detailed standards or procedures for GMP compliance.

The industry has previously argued that penalties under this system are excessively harsh, while also pointing out that criteria such as ‘repeated’ within the legally stipulated regulations lack clarity.

Therefore, this amendment to the Pharmaceutical Affairs Act introduces intermediate regulations that allow for the suspension of GMP certification for up to 6 months and corrective orders to be issued, depending on the severity of the violation, when simple errors occur in GMP record-keeping or when there are minor issues in GMP compliance or operation.

Furthermore, a new regulation has been established stipulating that pharmaceutical companies that fail to create or retain GMP records will have their certification immediately revoked, similar to cases of false or fraudulent certification. This aims to prevent deliberate failure to prepare GMP records to evade certification revocation.

Since the revocation system took effect, GMP certification revocations were notified to 8 companies as of last October, beginning with Hutecs Korea. Of these, 5 companies are currently pursuing administrative litigation, while penalties for 3 have been finalized.

An MFDS official stated, “In principle, the amendment to the Pharmaceutical Affairs Act cannot be applied retroactively. Companies currently involved in litigation may submit opinions regarding the amendment, but legislative changes and lawsuits are separate matters.”

This suggests that the MFDS intends to continue defending its position in court against companies that have filed lawsuits.

The MFDS official stated, “We understand that once this revised Pharmaceutical Affairs Act is promulgated, it is expected to take effect one year later.  Accordingly, we plan to proceed with revising the details in accordance with the legal provisions through amendments to the Prime Ministerial Decree (Regulations on the Safety of Pharmaceuticals).”

The reason opposition lawmaker Jong-heon Baek of the People Power Party joined the MFDS in pursuing this amendment is that, after Baek spearheaded and passed the initial Pharmaceutical Affairs Act amendment addressing the revocation of GMP compliance certifications, the industry flooded the MFDS with requests for further revisions.

In response, Rep. Baek’s office requested that the MFDS conduct research on potential improvements, ultimately leading to the current legislative proposal. The amendment is jointly sponsored by Rep. Mi-hwa Seo of the Democratic Party of Korea, reflecting bipartisan support for refining the system.