The U.S.-Japan Regulatory Reform and Competition Policy Initiative issued its sixth report this June. The report outlined various recommendations to facilitate economic growth and increased trade between the two countries, including plans for the medical device and pharmaceutical market. Most of the recommendations for medical devices and pharmaceuticals aimed at streamlining the product registration and approval process.
The Pharmaceuticals and Medical Devices Agency (PMDA) plans to address drug approval lag through various means, such as increasing the number of drug reviewers from 193 to 236 by 2010. The PMDA also plans to improve the environment for clinical trials, including increasing clinical research staff at 40 locations. In addition, the PMDA will provide manufacturers increased opportunities for clinical trial consultations and reduce consultation waiting times from three to two months by 2009. Through these changes and others, the PMDA hopes to reduce the pre-application process by 1.5 years and the application review period by 1 year.
In addition, Japan plans to provide opportunities for the US industry to discuss reforms of the Japan drug pricing system, frequency of price revisions, and re-pricing criteria for market expansion. The US industry will also have the chance to participate in discussions on the distribution of ethical drugs and methods for rewarding product innovation.
Japan also plans to focus on the blood products industry market, vaccine development, and in-vitro diagnostic pricing and reimbursement.
For medical devices, the PMDA plans to increase the number of medical device reviewers by 30 percent by 2009. In addition, there are plans to form a task force to improve reviews of medical device technological upgrades and clarify raw material data requirements for medical devices. This task force would also specify when a product change requires a partial change application or a simple notification to the PMDA. Other plans include providing the US medical device industry the opportunity to discuss reimbursement policies and pricing procedures.
By implementing these changes, both Japan and the US hope to stimulate the medical device and pharmaceutical markets, streamline product registration and decrease the regulatory approval processing time.