TOC prevents the first approval of COVID-19 vaccine in Korea

Imported new drugs must submit the country's manufacturing and sales certificate (CPP)

The MFDS promotes deletion of new drug CPP submission regulations

There are other rules for submitting certificates

This is a response from the health authorities to concerns that the COVID-19 vaccine developed by AstraZeneca will be introduced in Korea in February-March next year, although approval by the US FDA is delayed.

 

The MFDS is independently screened regardless of overseas institutions.

 

However, Korea's licensing regulations require approval from other manufacturing and marketing countries, if FDA fails.

 

The reason why the domestic authorities believe that the AstraZeneca vaccine can be introduced in February-March is that it is highly likely to be quickly approved by the UK MHRA or European EMA, not the FDA.

 

According to Article 4 (1) 4 of the Regulation on Safety of Pharmaceuticals, etc., in the case of imported products, a manufacturing certificate certifying that they are properly manufactured according to laws and regulations by the government of the producing country or public institution, and the government or public institution of the country where the license is registered.

 

A CPP must be submitted demonstrating that it is being marketed properly.

 

In the pharmaceutical industry, this is called CPP (Certificate of Manufacturing Sales in Importing Country).

 

It must already be used in another country to meet the CPP submission requirements.

 

Therefore, the Ministry of Food and Drug Safety cannot approve the world's first overseas drug development.

 

As AstraZeneca's COVID-19 vaccine is also the world's first overseas drug, the Ministry of Food and Drug Safety cannot approve it first.

 

However, as it is a vaccine made in an urgent situation called Corona 19, there is a possibility of applying an exception.

 

The MFDS has applied the CPP submission obligation only to imported new drugs.

 

And at a briefing session on the 17th, the MFDS announced that it would completely abolish the submission of new drug CPP data.

 

The MFDS said in a press release at the time, "Considering that The MFDS is conducting an independent review on safety, efficacy and quality, we will abolish the obligation to submit manufacturing and sales certificates, which are procedural regulations applied to imported new drugs." With the abolition of CPP, the MFDS was also able to license the world's first overseas drug development.

 

The pharmaceutical industry also welcomes the complete abolition of CPP submissions.

 

Although CPP has been abolished, documents proving data such as non-clinical trials or clinical trials submitted to the previous licensing countries must be submitted.

 

An official in the industry explained, "It is called a TOC (Table of contents) certificate, and it is a document that proves that the same data was produced in the country where it was previously licensed.

 

The country receiving this data should refer to the reference of the country prior to the license." Although the obligation to submit the CPP is abolished, the TOC certificate must be submitted as it is, so the first foreign drug can still be approved by the MFDS only after obtaining permission from another country.

 

An official in the pharmaceutical industry said, "Korea has been classified as a CPP-dependent licensed country so far.

 

It was backwards considering its status as a member of the ICH (International Drug Regulation and Harmonization Committee) or PIC/s (Pharmaceutical Initiative Mutual Cooperation Organization)." Explained.

 

He said, "We expected the abolition of the CPP to lead to increased confidence in the domestic drug approval system.

 

However, it is still difficult to approve the first overseas drug development because of the TOC certificate." He stressed, "To get out of the stigma of an underdeveloped country for permit screening as soon as possible, we must abolish the TOC certificate rather than request it." The MFDS aims to make an administrative notice within this year and complete the revision in the first half of next year on the regulations containing the abolition of the submission of imported CPP data.

 

However, it is said that the content of the revocation of the TOC certificate has not been published.