[Reporter's View] Enhanced GMP reg for sterile drug products

to take effect soon. Are companies prepared for the revision?

Starting December 27, production·good manufacturing practices (GMP) regulations for sterile medicinal products produced by aseptic processing will be strengthened.

 

The Ministry of Food and Drug Safety (MFDS) amended the 'Regulations on Good Manufacturing Practices (GMP) for Medicinal Products' in 2023.

 

The revision had been conducted to modify the production·good manufacturing practices (GMP) regulations for sterile medicinal products following the Pharmaceutical Inspection Convention (PIC) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) ahead of the reevaluation by the PIC/S.

 

The guidelines state the establishment of contaminant management methods through GMP regulations and the latest sterile manufacturing equipment and technology.

 

However, considering all pharmaceutical companies to have adequate preparation time to establish contaminant management methods, the MFDS announced the implementation of the regulations on sterile medicinal products two years after the notification.

 

Companies must establish a contaminant management strategy for sterile medicinal products starting in December and undergo risk assessment for PIC/S regulations and gap analysis.

 

To accomplish these tasks, manufacturing plants' divisions must begin working together 1-2 years before implementing the regulations.

 

Research and related technology investments are needed to prepare for the 'Pre-Use Post Sterilization Integrity Testing (PUPSIT).' Until now, manufacturing companies that have not established contaminant management strategies will not be able to meet the standards for strengthened GMP measures starting in December.

 

Due to this update, manufacturing companies with old manufacturing equipment announced suspending their productions.

 

Several companies, including Pharma I, Pharma B, Pharma G, Pharma D, Pharma A, and Pharma K, have reported to the MFDS.

 

These companies anticipated replacing old equipment following the PIC/S would cost billions in Korean won.

 

Therefore, they resorted to switching to CMO and discontinuing injectable line facilities that do not generate profits compared to investments due to low reimbursement ceiling caps.

 

In fact, there were calls for facility investment costs and pricing support even during the briefings held for manufacturers ahead of the revision of the sterile medicinal products GMP regulation.

 

However, the MFDS believed that the 2+1-year grace period would give manufacturers sufficient time to adapt, and it did not introduce any additional support measures.

 

As the regulation’s enforcement date approaches, companies are beginning to withdraw from injectable production, and organizations such as the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) have stepped in to survey the state of the industry.

 

There are currently approximately 110 aseptic-preparation manufacturers in South Korea.

 

Of these, about 10% have already announced plans to suspend production.

 

If many manufacturers shut down their facilities simultaneously before the implementation date, there could be a shortage of injectable products.

 

If this includes designated National Essential Medicines, the crisis could escalate uncontrollably.

 

Instead of pointing to the fact that the MFDS already completed briefings, public comment, and a grace period during the regulation revision process, it needs to listen to what manufacturers require.

 

Related parties must jointly consider support measures for aseptic‐preparation companies, such as assistance with developing contamination‐control strategies and options like price increases for injectable products.

 

There will inevitably be challenges in securing new personnel or installing new facilities under the new system, such as freeze dryers and sterilization equipment.