Asia Wide Regulatory Unity Needed to Accelerate Path of Drugs to Market

Harmonizing the regulatory environment across Asia and making it easier to get drugs to the market should be the priority for government agencies across the continent, said participants at the DIA’s Asia New Drug Conference in Tokyo earlier this month.

“We need to collaborate and compete with each other to survive,” said Toshiyoshi Tominaga, of Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). “If Asian countries collaborate, we can take advantage of common diseases, geographical proximity . . . similar cultures, and our growing population and economy.”

In order to facilitate cooperation, Tominaga suggested that nations get together and harmonize regulations for drug development, in order to get products to market faster.

Hsueh Yung Tai, deputy director of the division of medicinal products at the Taiwan FDA, said her country would offer its full support to Tominaga’s proposal.

“We totally support Dr. Tominaga’s proposal for pan-Asian regulatory harmonization,” she said. “It will help, especially with safety issues for patients. We will give our very strong support for this idea,” she noted.

Many attending the conference also welcomed the proposal.

“It would definitely be a good thing,” said Jasper Jiang, vice general manager at China-based Rundo Pharmaceutical Research and Development Co. Ltd., a clinical research organization, “especially as East Asia begins bringing more and more drugs to market.”

Jiang’s company is a part of the Alliance for Pacific Asia Clinical Trials, alongside AC Medical Inc., of Japan; C&R Research Inc., of South Korea; and Virginia Contract Research Organization Co. Ltd., of Taiwan.


Challenges to Harmonization

Achieving such harmonization will be tough, however. Even definitions can be different from one country to the next.

For example, South Korea defines new drugs as those that “contain chemicals never before seen by the Ministry of Food and Drug Safety,” according to Kim Sun-young, assistant director at the clinical trials management division of the Pharmaceutical Safety Bureau of the Ministry of Food and Drug Safety (MFDS).

In China, the situation is completely different. Beijing defines a new drug as one that has not been marketed in China and is looking at changing that to refer to drugs that have not been marketed either inside or outside of China.

Another hurdle is that medical practices across the region vary, and local interpretation can diverge.

“We have spoken of regulatory convergence, and this is important,” said Min Soo Park, professor of pediatrics and clinical pharmacology at Yonsei University College of Medicine in Seoul. “In Korea, we say we have adopted [International Council on Harmonization] guidelines, but it is my opinion that we adapted them. In Asia, we need an agreement to adopt guidelines, but actual application and interpretation of the guidelines could be so different. We can try to minimize these differences through communication, and that should be the case.”

Another issue is the youth of some of the markets where medical research is being conducted. In South Korea, for instance, investigational new drug (IND) protocols for medical development were put in place only in 2002.

“After introducing the IND system in 2002, approval of clinical trials rapidly increased,” said Myung-jung Kim, director of the clinical trials management division at South Korea’s MFDS. At the year of launch, 45 clinical trials were approved; last year, 675 were given the go-ahead.

On the other hand, there are multinational agreements in place that could facilitate more harmonization.

Taiwan, for example, is working to bring its regulations on intellectual property in line with those of countries that make up the proposed Trans Pacific Partnership trade deal. In addition, “Taiwan has a cooperation relationship with Japan and also joined the International Generic Drug Regulators Program,” said Hsueh Yung Tai, deputy director of the division of medicinal products at the Taiwan FDA. “Under this, we share information with the EU, Health Canada and others.”

For almost all participants at the conference, rules in China, where 100 subjects or 300 subjects are often required as an arbitrary number in clinical trials, are a major stumbling block to bringing about regulatory convergence.

“If there is a scientific justification for a bigger sample, then who can argue with that?” Tominaga asked. “But if there is a need to use a bigger sample, because of a local culture or because we need to satisfy some regulatory requirement, then we have a political mess.”

And yet, solving that could be essential. Asian countries are increasingly looking at Europe, which acts as essentially one area, and are beginning to consider that Asia would have more power and influence if countries could work together.