"Phase III trial exemptions for combi"

Changes are expected regarding to clarifying document submission requirements and new product development

The Drug Evaluation Department of the MFDS National Institute of Food and Drug Safety Evaluation held a session at its Osong headquarters on November 25, inviting press reporters to explain the medical product field tasks as part of 'The Top 50 Food and Drug Safety Tasks.' (Juhye Kang, Director General of the Drug Evaluation Department, gives remarks)

The pharmaceutical industry is giving favorable review of the pharmaceutical regulatory reform that the Ministry of Food and Drug Safety (MFDS) has selected as its 50 major tasks.

The task of stipulating exemptions from Phase III trials for disease-comorbidity combination drugs is attracting attention, with the MFDS expected to lead the world, as it has with biosimilars. There is also the view that clarifying document submission requirements for Over-the-Counter (OTC) drugs may enable greater imagination in new product development.

Notably, ​an analysis suggests that this task is particularly significant, as it was developed by the pharmaceutical industry and the CHannel On RegUlatory Submission & Review (CHORUS).

The Drug Evaluation Department of the MFDS National Institute of Food and Drug Safety Evaluation held a session at its Osong headquarters on November 25, inviting press reporters to explain the medical product field tasks as part of 'The Top 50 Food and Drug Safety Tasks.'

Pharmaceutical officials who contributed to the task formulation were also present at this session. Juhye Kang, Director General of the Drug Evaluation Department, said, "We discovered tasks needed in the field while exchanging many opinions with the pharmaceutical industry on what is rational," and added, "Task discovery began from discussing 'Can we develop more diverse OTC products?' and 'Can we rationalize data submission for combination drugs, similar to biosimilars?'."

First, the Ministry plans to revise the combination drug clinical trial guidelines within the year so that approval for hypertension·hyperlipidemia combination drugs is possible with only a Phase I clinical trial.

Kim So-hee, Head of the Circulatory and Neurologic Drugs Department, stated, "In the situation where the development of hypertension-hyperlipidemia combination drugs exceeds 10 years, the MFDS analyzed Phase III data from 28 products involving approximately 5,000 subjects," and added, "As a result, the two components did not affect the therapeutic efficacy, and there were no safety concerns to worry about."

Based on this result, the data scope is being rationalized so that approval for a hypertension-hyperlipidemia combination drug can be obtained with only Phase I clinical trials, rather than Phase III.

Regarding this, Gil Chan-ho, Senior Managing Director of Sama Pharm, said, "The statement about exempting Phase III clinical trials for combination drugs for co-morbidities is not specified even in overseas guidelines," and added, "However, after reviewing it from various angles, we judged that it is scientifically and regulatorily valid."

Gil continued, "When we began discussions in the Combination Drug Consultative Body, we thought the foundation for South Korea becoming a biosimilar powerhouse was the MFDS's global leadership in regulation," and applaued, saying, "Among combination drugs for co-morbidities, drugs where Phase III clinical trials are unnecessary can enter overseas markets faster through the relevant regulation, and we also believe this regulation is a major movement that overseas regulatory bodies can adopt."

If Phase III clinical trials are exempted for hypertension-hyperlipidemia combination drugs, data protection benefits will not be granted. ​The explanation is that the pharmaceutical industry judged that, nonetheless, saving Phase III costs leads to a virtuous cycle of better product development.

An industry official also added that combination drugs for co-morbidities were not designated initially as subjects for incrementally modified drugs, so this part was also considered.

​"Broadening imagination for OTC product development with formulation changes"

The part clarifying OTC drug data submission was prepared to revitalize the development of OTC products through formulation changes by providing the necessary data in the guidelines.

For example, it specifies that comparative dissolution data may be omitted when changing a similar component, same-route-of-administration ointments to a gel.

Regarding this, Sung-woo Jung, Team Leader at Genuone Sciences, applauded, saying, "This amendment provides the pharmaceutical industry with new ground that can bring change," and added, "The expansion of Standard Manufacturing Criteria is actually limited (for OTC product development), but (with this amendment) we can unleash the wave of new imagination."

For example, it was difficult to prove equivalence during formulation changes because matching PH and concentration was challenging.​However, the analysis is that the area of new product development will widen significantly if the guidelines exempt data for proving equivalence.

The assessment is that the pharmaceutical industry analyzed the Japanese system and suggested these parts when the consultative body started in April. With the MFDS's acceptance, a technically infeasible area has been opened.

The MFDS plans to expand patients' options for medicines by supporting product development through the implementation of these drug regulatory reforms, including revising the Regulations on marketing authorization·reporting·review of pharmaceuticals by the end of next year.