[Reporter's View] Strengthening GMP for sterile drugs

Gov’t needs to consider the companies’ position while strengthening GMP standards for sterile drug products to ensure a stable supply

The government has reaffirmed its existing position on strengthening GMP standards for sterile finished drug products in December.

 

The Ministry of Food and Drug Safety recently met with sterile drug factory managers and stated that there will be no postponement of the enforcement of the “Regulations on Drug Manufacturing and Quality Control” in December.

 

Under these regulations, facilities producing sterile drug products must implement the following measures: ▲Establish and implement a systematic contamination control strategy for the manufacture of sterile drug products; ▲Develop individual good manufacturing practices (GMP) for advanced biopharmaceuticals; ▲Clarify the details of the specific dosage forms, evaluation procedures, and methods for determining compliance with the good manufacturing practices (GMP).

 

The MFDS has been preparing for the implementation of these measures since joining the Pharmaceutical Inspection Co-operation Scheme (PIC/S) in 2014.

 

The MFDS believed that it was necessary to strengthen GMP standards for sterile products in line with international standards.

 

To this end, the MFDS has provided the pharmaceutical industry with sufficient time.

 

When revising relevant regulations in 2023, the MFDS required manufacturers of sterile finished drug products to replace outdated equipment within 2 years after the revision of the notice, and manufacturers of sterile APIs to do so within three years.

 

Additional grace periods were granted for certain provisions.

 

However, as the deadline for implementing the new regulations approaches, an increasing number of pharmaceutical companies are refusing to replace their outdated equipment.

 

Instead of halting production of sterile drug products, they plan to shift production to contract manufacturing facilities.

 

This is because replacing outdated equipment could cost tens of billions to hundreds of billions of won, depending on the facility.

 

At first glance, this seems as if aseptic drug manufacturers are considering production halts to save equipment replacement costs.

 

Additionally, given the sufficient timeframe provided, it seems that they have not been reacting for the past two years and only decided to halt production as the deadline for stricter regulations approaches.

 

However, the story of sterile drug manufacturing plants is different.

 

Their common claim is that the productivity of sterile drug manufacturing itself has become too low, regardless of the need to replace outdated equipment.

 

In a situation where profits are almost nonexistent due to excessively low drug prices, they argue that they have no choice but to halt production, as additional costs of up to hundreds of billions of won would be required for replacements.

 

For this reason, the pharmaceutical industry requested support for facility investment costs and improvements to the drug price structure during several recent meetings with the MFDS.

 

However, the MFDS has drawn a line, saying that it will not provide investment support as it has already provided a sufficient grace period.

 

Discussions on pricing sterile drugs have also stalled.

 

If this situation continues, there are concerns that the supply shortage of sterile drug products will worsen by the end of the year.

 

Already this year, 22 cases of injection supply discontinuations or shortages have been reported.

 

It is known that about 10 sterile drug factories are seriously considering discontinuing production.

 

If they discontinue their product supply by the end of the year, there are concerns that it will lead to a large-scale supply shortage.

 

I agree with the policy direction that GMP should be strengthened to meet international standards.

 

However, before doing so, we must first address the fundamental problem of low productivity.

 

The MFDS must not dismiss the demands of sterile drug product manufacturers as “lack of preparation.” Unless the fundamental problems of excessively low drug prices and the resulting low productivity are resolved, it will be difficult to encourage sterile drug product manufacturers to participate, no matter how long the grace period is.