GMP “one-strike” rule to be eased… suspension introduced

National Assembly and MFDS to create mid-level sanctions before revoking GMP certification

Failure to prepare or retain GMP records will result in immediate certification revocation

Detailed GMP Regulations…Simple errors result in a 6-month suspension as ‘reasonable remediation’

The National Assembly and the government are launching a comprehensive overhaul of the “one-strike out” (immediate revocation) system for pharmaceutical GMP (Good Manufacturing Practice) compliance violations.

This approach introduces an intermediate regulatory step: adding a ‘GMP suspension’ penalty before immediate revocation, depending on the severity of violations related to the manufacturing record. The suspension period can be set for up to 6 months.

At the same time, a new provision will mandate immediate revocation of GMP certification for companies that fail to prepare, properly retain, or intentionally discard GMP records, equating such conduct with obtaining certification through false or fraudulent means.

The reform aims to address concerns that the current system, which focuses heavily on the ‘repeated nature’ of GMP manufacturing record violations by pharmaceutical companies, has led to some unreasonable penalties.

On the 27th, Rep. Jongheon Baek of the People Power Party and Rep. Mi-hwa Seo of the Democratic Party of Korea jointly introduced amendments to the Pharmaceutical Affairs Act to rationalize GMP regulations.

The bipartisan push for legislation to improve the GMP one-strike-out system was influenced by the Ministry of Food and Drug Safety (MFDS) commissioning and completing a research project based on industry complaints.

Previously, amid incidents involving unauthorized manufacturing and falsified GMP records, the MFDS and the National Assembly strengthened GMP sanctions to prevent recurrence.

As a result, the one-strike-out system for GMP compliance violations of pharmaceutical companies was implemented in December 2022 following National Assembly legislation.

However, since the law's enactment, pharmaceutical companies whose GMP certifications were revoked by the MFDS have repeatedly filed administrative lawsuits challenging the decisions. As shortcomings in the system became apparent, calls for improvement emerged from both the pharmaceutical industry and the National Assembly.

Complaints frequently arose that immediate revocation of GMP certification not only halts a pharmaceutical company's drug production lines but also causes significant operational damage to contract manufacturers tied to the penalized company, necessitating pre-revocation regulatory measures.

Specifically, pharmaceutical companies criticized the current GMP one-strike-out system as excessive punishment. They argued it applies the criterion of ‘repeated false or erroneous record-keeping’ without considering the severity of the violation (such as falsifying manufacturing records), its impact on human health, or the presence of intent.

Pharmaceutical companies pointed out that focusing solely on repetition for GMP certification revocation can result in lighter penalties for serious violations compared to minor infractions and does not adequately account for intent.

Consequently, some companies reportedly resorted to intentionally not preparing or discarding GMP records to avoid revocation triggered by repeated documentation errors.

In response, the MFDS initiated a research project on the GMP compliance certification system and advanced supplementary legislation in collaboration with the National Assembly.

The core revision introduces ‘GMP certification suspension’ as an intermediate sanction between corrective orders and full revocation. This penalty will be applied based on the severity of the GMP violation and its impact on drug quality.

Notably, companies that fail to prepare or retain GMP records will face immediate revocation, targeting attempts to evade penalties through deliberate non-documentation or record destruction.

Additionally, a new intermediate regulatory measure was established, allowing for a 6-month suspension of GMP certification for relatively minor GMP violations.

The MFDS and lawmakers Jong-heon Baek and Mi-hwa Seo, who proposed the bill, plan to collaborate on advancing GMP certification revocation regulations through swift legislation.