Strengthen the Adverse Event Analysis

As reported in this column in the last issue of Medical Product Outsourcing, a more timely medical device evaluation plan will begin in April. Along with this new plan, the Ministry of Health, Labor and Welfare (MHLW) and its evaluation agency, the Pharmaceuticals & Medical Devices Agency (PMDA), are going to reinforce the post-marketing surveillance system beginning in April. Within the next five years, the PMDA will hire nearly 100 additional officers, more than doubling current levels.

The goal is to strengthen the system and organization to analyze and resolve adverse events or complications being reported in the marketplace after device approval, as well as to provide safety information to the market quickly. As highly effective drugs or revolutionary new medical devices increas-ingly become available, serious adverse incidents often occur.

At present, the monitoring and analysis of such adverse events are not well organized in Japan compared with the United States and Europe.

Adverse events or complications are generally reported to PMDA either by physicians in charge or a device or pharmaceutical supplier in as timely a manner as possible.

With PMDA’s analysis, MHLW announces the warning to the market and instructs the manufacturer or suppler to prevent further occurrence of adverse events by correcting or amending the information for use to avoid the same incidents.

Currently, about 130 incidents are reported on a daily basis, but only about 40 events, mostly serious or fatal cases, are resolved every day.

In the United States, the FDA has about 2,900 reviewers for evaluation and safety analysis. The European Union has about 440, and each member country has their own reviewers. Japan has about 310 officers, including MHLW and PMDA, and its safety division has only 66 officers in charge. To cope with quick safety measures, PMDA will hire an additional 100 specialists such as physicians, pharmacists, engineers and statisticians. In addition to an increase of reviewers for new medical devices, MHLW and PMDA are taking steady steps to cope with quickly advancing medical technologies.

Yoshio Mitsumori is the president and CEO for Tokyo-based ADMIS, a consultant specializing in the medical device industry. He has more than 25 years of experience in the medical industry, including positions with the Itochu Corp., U.S. Surgical, National Medical Enterprises and Century Medical. A member of RAPS, he has spoken at many industry events and worked extensively in international trade of medical products and technologies. He can be reached at [email protected].