Rx drugs,allowed according to CTD starting from next year

The Regulation on Drug Product Authorization, Declaration, & Review", "Medical Equivalence Test Standard Revised Notice on the 11th

Foreign Pharmacopoeia evidence exemption regulations will be deleted

Disposable eye drops, 0.5ml or less.

The MFDS announced on the 11th that it will partially revise the Regulation on Drug Product Authorization, Declaration, & Review to secure the quality reliability of generics in accordance with international standards.

 

The revision includes improving the management of manufacturing methods such as Rx drugs manufacturing processes, deleting some submission data exemption regulations upon approval based on foreign drugs, process documents, and specifications, establishing standards for packaging disposable eye drops, and listing active ingredients in the product name.

 

Accordingly, from November 12 next year, when licensing Rx drugs, it will be improved to describe in detail according to CTD when describing manufacturing methods such as manufacturing processes.

 

Currently, it is summarized mainly in major manufacturing processes.

 

In addition, the manufacturing method of the product submitted by CTD will be changed.

 

Some submission data exemption regulations will be deleted upon permission based on the acceptance of foreign pharmacies, process documents, and specifications (Pharmacopoeia).

 

Some data, such as toxic and pharmacological data, could have been exempted if they were listed in a foreign drugstore, but in the future, they will be required to submit data to examine safety and effectiveness based on scientific evidence.

 

Along with this, a new standard for limiting the packaging unit of disposable eye drops will be established.

 

In order to relieve public anxiety caused by the reuse of disposable eye drops and to provide a safe use environment for medicines, the packaging unit considering the amount of eye drops used once is defined as 0.5ml or less.

 

Only single-component drugs are currently marked with active ingredients in the product name, but in the future, information provision will be expanded by marking active ingredients in the product name of combinations with three or less main ingredients.

 

The revision to the drug equivalence test standards includes the preparation of biological equivalence test evaluation standards reflecting the formulation characteristics of enteric agents, and harmonization of international standards and regulations for biological equivalence test exemption standards according to the BCS.

 

From November 12 next year, criteria for evaluating biological equivalence tests reflecting the characteristics of preparations of Enteric-coated preparations will be prepared.

 

Starting today, the BCS exemption criteria for biological equivalence tests will be met with international standards.

 

In accordance with the enactment of the ICHM9 guidelines, the standards for exemption from biological equivalence tests for drugs will be newly established to align international and domestic regulations equally.

 

The MFDS said it expects the revision to raise the quality of medicines to the next level, and it will strengthen its drug licensing and management system based on Regulatory Science so that doctors, pharmacists, and patients can use quality drugs with confidence.

 

Details can be found on the MFDS' website (mfds.go.kr > statutes/data > statute information > amendment notice, etc.).