GMP issues causing delays in new drug approval

The average waiting time per medicine is over 20 months.

A preliminary examination of drugs that are in high demand within society should be implemented.

The bottleneck in Good Manufacturing Practice (GMP) assessments is causing delays in the approval of global pharmaceuticals.

The GMP process, which inspects the manufacturing facilities for pharmaceutical products, has been identified as a contributing factor to the delay in the approval of pharmaceuticals.

 

The Ministry of Food and Drug Safety (MFDS) has acknowledged the issue, but they have not yet addressed alternative solutions.

 

Consequently, the bottleneck in GMP for global pharmaceuticals awaiting approval is worsening.

 

To gain approval for pharmaceuticals in Korea, pharmaceuticals undergo a series of evaluations, including safety and effectiveness evaluation, Good Manufacturing Practice (GMP) evaluation, and quality evaluation.

 

Among these, the GMP evaluation examines the manufacturing facility of the pharmaceuticals seeking approval, and pharmaceuticals produced in international facilities, including global pharmaceuticals, may require an on-site audits as part of the process.

 

The MFDS has demonstrated flexibility in its policy management over the past three years, including implementing remote GMP audits during the COVID-19 pandemic.

 

However, as the audits have shifted back to full on-site audits, concerns are arising about the backlog in audits.

 

According to the industry, these policy changes are exacerbating the backlog of GMP on-site audits for global pharmaceuticals.

 

Currently, the average waiting time per drug is over 20 months.

 

This delay in the domestic approval schedule is particularly problematic for pharmaceuticals, including new drugs and other formulations of already licensed drugs.

 

What would be the solution?

 

During the National Assembly's audit, In Jaekeun, a member of the Health and Welfare Committee from the Democratic Party, raised questions to the MFDS regarding the delay in on-site audits of overseas manufacturing facilities, which has led to the issue of global pharmaceuticals not being supplied to domestic patients in a timely manner.

 

In response to the question about the status of backlog in the GMP on-site audits for global pharmaceuticals, "Our analysis is that on-site audit backlog has worsened due to the inability to conduct on-site audits at global pharmaceutical manufacturing facilities during the Covid-19 pandemic," an official of the MFDS's Pharmaceutical Quality Division answered.

 

In response to the question about specific plans to address the backlog in GMP on-site audits for global pharmaceuticals, "We are working on increasing manpower of GMP investigators responsible for conducting on-site audits," an official stated.

 

Currently, there are 16 GMP-related personnel within the MFDS's Pharmaceutical Quality Division.

 

Based on the schedule of GMP investigators for on-site audits posted on the MFDS website, 11 investigators were scheduled to undertake international business trips for conducting on-site audits in December of last year.

 

The solution proposed by the MFDS, which involves increasing manpower for GMP audits, has a potential pitfall.

 

It requires securing the budget in advance, and the recruitment of new personnel for the division takes time.

 

This means that the MFDS's suggested solution takes some time to implement effectively.

 

The ongoing backlog of global pharmaceuticals awaiting GMP audits in Korea has significant implications for patients waiting for these medications.

 

While increasing manpower is a long-term solution, it's crucial to implement short-term measures to address the immediate problem and reduce delays in approval processes.

 

The pharmaceutical industry has proposed an alternative solution, suggesting a preliminary examination of pharmaceuticals that are in high demand within society.

 

The suggestion aligns with the direction of MFDS.

 

MFDS had announced that they will prioritize conducting an investigation of the pharmaceuticals meeting the following criteria: ▲Pharmaceuticals designated for preliminary examination according to Article 35-4 of the Pharmaceutical Affairs Act, ▲National essential drugs designated as requiring administrative support according to Article 83-4 of Pharmaceutical Affairs Act.

 

"The current criteria for selecting pharmaceuticals for preliminary examination include drugs for the treatment of severe or rare diseases, and in cases where there are ▲no alternative pharmaceuticals, ▲medical gaps due to supply shortages, or ▲when there is a possibility of replacing pharmaceuticals experiencing supply shortages, GMP on-site audits should be prioritized," a pharmaceutical company's approval authority stated.

 

Furthermore, the pharmaceutical industry emphasizes the need to expedite the revision of national essential drugs.

 

Since the change of administration in 2022, national essential drugs have been excluded from policy priorities.

 

It was only in November, almost two years after the last update in December 2021, that some pediatric drugs were added to the list.

 

Many essential drugs required in the healthcare field are still waiting for approval.

 

Therefore, there is a suggestion to consider designating these essential drugs as new national essential drugs to address this issue.