In Asia, regulatory harmonization in med tech clashes with the reality on the ground level

November 9, 2016 – 6:09 PM | By Omar Ford | No comments yet

By Haky Moon Staff Writer

SINGAPORE – Harmonization of regulations throughout the Asia Pacific region has been an ongoing goal in the past 20 years, but regulators across the region are now coming to accept that this particular goal may never be achieved.

Regulators and industry stakeholders meeting in Singapore starting Tuesday for the Asia Pacific Medtech Forum 2016 said complete regional regulatory harmonization would be nice but is unlikely.

While there has been some progress, a “harmonized regulatory environment will be impossible,” said John Lim, deputy director of medical services at the Ministry of Health of Singapore.

“If you look at harmonization, that term quite frankly is something not very achievable. Because it assumes that everything must be exactly the same. Convergence is a far more achievable objective where you are lowering the differences,” said Lim, who used to work for Singapore’s Health Sciences Authority (HAS).

Lim’s counterparts from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) put forward a similar message.

Different regulators have different lead times and capacity constraints. Companies will have to get used to dealing with such differences.

“[The] PMDA is trying to shorten the regulatory lead-time, but we need higher qualified persons, but I’m not sure if we can find those kinds of people right now,” said Jun Kitahara, director at the division of regulatory cooperation office of international programs at the PMDA, which itself was established in 2004.

But complete harmonization across the region may not be entirely necessary.

“Harmonization is not the only way to drive the cycle time,” said Tran Quan, vice president regulatory affairs of APACMed, which organized the forum. “I also observed that in this region there has been tremendous improvement.”

Industry stakeholders have long floated the idea that countries across southeast Asia, particularly members of the Association of Southeast Asian Nations (ASEAN), which includes Singapore, could develop a common system like the European Union.

The challenges, however, are enormous and driven by the huge differences between the member countries. Cambodia, Laos and Myanmar, for example, are among the poorest and least developed countries in the world. Malaysia, on the other hand, is a wealthy middle income country and Singapore is one of the richest and most developed places on Earth. The differences are multiple times greater than those that exist even between the poorest and wealthiest nation in the EU.

“Many years back, a pharmaceutical company came and asked why can’t we have a common ASEAN system like the EU? First, there is no legal framework for that. And there is a significant capacity divergence across the countries, which also means in terms of knowledge of handling. These are issues that are obstacles, when companies approach various national regulatory authorities,” said Lim.

“Sometimes the [national regulatory authorities] might not be in a confident position to handle some of the machines,” he said. On top of that, “language will also be one of the issues.”

These relatively common language barriers are one impediment to the implantation of the ASEAN Medical Device Directives (AMDD), an attempt to develop a common dossier for the 10 ASEAN member countries. The AMDD is non-binding and has no deadlines for implementation and adoption has been uneven.

With that said, raising the quality of regulation in a single country might be an easier task.

“One example that I was able to experience 10 or 15 years ago was in South Korea. It was the way that the South Korean FDA was driven to raise their regulatory standards to global standards. South Korea used to have a gap. They had to make the regulatory environment world class if they wanted to be in the global bio capability scene,” said Patrick Holt, president of medical products, at Cardinal Health Asia Pacific.

“There are different cultural as well as clinical practices around the world. We can converge into this model of reliance and try to rely more on each other’s approvals. That’s been happening for drugs. Maybe a day will come when we can share the same information for medical devices,” said Raymond Chua, Group Director, at the HSA.

There have been some efforts toward this goal on the global stage.

Last month in Brazil, the International Medical Device Regulators Forum put forward three guidance documents intended to provide a harmonized approach to terminology and codes used in adverse event reporting, methodologies for analyzing registry data and the clinical evaluation of software as a medical device.

“Overall, the drive towards greater efficiency is definitely there, and I think there are efforts… towards harmonization,” said Quan.


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