How current regulations effect product development strategies
The life sciences market in Japan, consisting of pharmaceuticals, medical devices, biologics and combination products, is huge by the standards of the markets in the neighborhood, such as China, Malaysia, Singapore and Australia. It compares with those of Europe and North America. The main reasons attributed for this are the high spending power of the population, high number and density of the population, the aging population and the huge spending on the healthcare sector on R and D and innovation, which result in high costs that have to be passed on to the consumer.
At this point of time, Japan is going through developments that have the potential to cause tremors, if not turbulence, in the life sciences market, particularly that of drugs. The annual potential for only drugs is pegged at ¥ 150 billion. In the backdrop of high unit prices of drugs, the government is keen to actively pursue a couple of major initiatives.
One, it wants to cut the price of generics, so that they reach out to a larger market base. Two, it wants to bring about improvements into the regulatory framework by focusing on regulations that ensure higher and easier postmarketing safety. The Japanese regulatory agency, the Pharmaceuticals and Medical Devices Agency (PMDA), is stepping up efforts to make changes into their IT systems, which will streamline the processes for filing clinical data for regulatory approval.
Makeover of its image
The PMDA also plans to recruit more manpower to tighten the overall regulatory process and bolster innovation in this sector to take it to even higher standards than it currently is in. the main purpose for which the PMDA is pushing for all these is to eradicate the impression that has gained ground, especially among western life sciences companies, that Japanese regulatory processes are laggardly and not up to the standards that can be expected from a country of its developmental level.
It is in the backdrop of these contexts that understanding what it takes to make regulatory filings in the life sciences in Japan acquires significance. An in-depth understanding of this topic will be the content of a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance.
At this webinar, Robert J. Russell, who is President of RJR Consulting, Inc., which assists the pharmaceutical, medical device and biotech industries in understanding and complying with International Regulations affecting compliance, new product development, manufacturing and Quality Assurance, will be the speaker.
To gain insights into how the regulatory filing requirements and compliance processes for Japan work, please enroll for this webinar by visiting http://www.compliance4all.com/control/w_product/~product_id=501369LIVE?Medium-SEO
Insights into the regulatory scene
At this session, Robert J. Russell will familiarize participants with the regulatory compliance requirements and procedures for pharmaceuticals, medical devices, biologics and combination products in Japan. He will help participants get an understanding of topics relating to pre-clinical and clinical requirements, as well as with the structure of the regulatory agencies in Japan.
While elaborating on the current regulatory climate in Japan; the speaker will offer examples of effective compliance procedures and techniques. He will describe the methods by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products and familiarize participants with a few common issues and concerns that professionals and firms dealing with Life Sciences usually face when they do business with Japan.
Japan’s utilization of the ICH standards
The speaker will also explain how Japan interacts with and utilizes ICH standards. He will also describe how Japan’s way of working with other national regulatory agencies influences their business. The webinar will show ways by which to address the conflicts that sometimes arise and suggest the optimal ways of doing this.
This course will provide insights into all the important areas of regulatory filing requirements and compliance processes for the life sciences in Japan. Its objectives are the following:
- What is the Regulatory Structure in Japan
- Understanding the specific procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products
- How to begin your company involvement in Japan
- How current regulations effect product development strategies
- Pricing issues
- Understanding the concerns/issues of Japanese Regulatory Personnel
- Understanding the Local Culture: How to negotiate with the regulators
- Information necessary for effective submissions
- Maintenance of Authorized Products
This is the outline for the course:
- Japan’s Regulatory Structure for the Life Science Product Industries
- Beginning Your Company Involvement in Japan
- Life Science Regulations and the Regulatory Processes in Japan
- Japan’s Use of ICH Standards/Principles
- Marketing Authorization Processes — Filings & Registrations
- Variations: Changes to Marketed Products
- The Do’s and Don’ts of Regulatory Involvement