[Reporter’s view] WLA Registration

WHO inspection exemption benefit is a key

WHO announced on October 26 that the Ministry of Food and Drug Safety was listed on the WHO Listed Authorities.

 

The news became known in Korea on the afternoon of the 30th, when WHO posted a list of WLA-registered countries on its website and then suddenly deleted it.

 

It was confirmed that the error was due to detailed coordination, and it was on the afternoon of the 31st that the Ministry of Food and Drug Safety officially heard the news of WLA registration.

 

WHO also officially distributed a press release and announced that Korea was listed in the WLA.

 

The good news about the Ministry of Food and Drug Safety's WLA is that although Korea is a full member of the ICH, it has not been listed on the WHO's SRA (Stringent Regulatory Authority), which means that the domestic pharmaceutical and bio industries have not been able to receive incentives in bidding for the procurement of medicines and vaccines from UN-affiliated organizations.

 

In particular, in 2021, when COVID-19 was prevalent, Hong Kong limited the scope of countries recognizing vaccination certificates to countries listed in the SRA, raising controversy over the reliability of the regulatory level of domestic pharmaceuticals.

 

This is a happening that occurred as the WHO has not been operating the SRA registration application process since 2015.

 

WHO has been promoting WLA, in which WHO directly evaluates regulatory agencies, since 2016 to replace SRA, which is based on ICH membership requirements.

 

Korea had no choice but to wait for an evaluation system to replace SRA since 2016, and submitted its first letter of intent for registration in 2021, when WHO began accepting letters of intention to register WLA.

 

The news of the Ministry of Food and Drug Safety's WLA registration is a great achievement after two years.

 

However, the specific incentives that the domestic pharmaceutical and bio-industry will experience once WLA registration is achieved are unknown.

 

The Ministry of Food and Drug Safety also provides advantageous conditions by applying exceptions to WHO quality certification (Pre-qualification (PQ)) when SRA countries bid for the procurement of medicines and vaccines from UN-affiliated organizations, and WHO provides equivalent standards to countries listed in the WLA.

 

The only announcement was that they expected to implement support measures.

 

The pharmaceutical bio-industry is expecting WHO's PQ exception to be applied through this WLA listing.

 

Although WHO is not a regulatory agency, it conducts PQ when procuring medicines and vaccines from UN-affiliated organizations, which includes data review, testing, and on-site inspection.

 

In the end, it seems that domestic sites will only be able to realize the Ministry of Food and Drug Safety's WLA registration if they are able to receive exceptions to WHO's PQ.

 

We hope that the Ministry of Food and Drug Safety will be able to announce in detail WHO's incentives for WLA registration as soon as possible.