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Interview

• Regulatory strategies in China: How to save cost and time
  Stefano Accorsi, Director of International Regulatory Affairs at Chiesi Farmaceutici S.p.A., Parma, Italy, speaks exclusively to Pharma IQ on the requirements for clinical trials design and regulatory environment in China; he also discusses the considerations and strategies for EU-Based pharma companies entering the China market.

Presentations

• ICSR submission requirements in Asian countries
  Jean-Christophe Delumeau, Head of Pharmacovigilance Asia-Pacific, Bayer HealthCare, Beijing
  Jean-Christophe Delumeau talks about ICSR Submission requirements in India, Indonesia, Vietnam, Cambodia, Thailand, Taiwan, China, Korea, Singapore and Japan.
• Pharma regulatory affairs and pharmacovigilance practices in Vietnam
  Hoang Anh NGUYEN, National Center for Drug Information and ADR monitoring & Hanoi University of Pharmacy, Hanoi, Vietnam
  Lack of priority-setting within national drug regulatory authority and public health programs has become the top challenge in pharmacovigilance practices in Vietnam.
• Principles of Drug Management for Malaysia
  Sameerah S. A. Rahman, National Pharmaceutical Control Bureau, Ministry of Health Malaysia
  Sameerah S. A. Rahman introduces the developments of Policies and Standards of Pharmacy Practice in Malaysia.
• Regulatory Requirements in Thailand
  Wimon Suwankesawong, Head of Health Product Vigilance Center, Food and Drug Administration,Thailand
  Wimon Suwankesawong discusses SMP procedures and guidance for Industry Post-marketing Safety Reporting Requirements for Human Drug and Biological Products in Thailand.

Articles

• China Drug and Device Regulatory Update 2009
  By Ames Gross and John Minot
  With a more immediate impact on the drug and medical device industry, many recent regulations have been raising standards for medical products to be allowed onto the Chinese market. China’s State Food and Drug Administration (SFDA) is continuing to crack down on drug and medical device quality in response to public outcry over a number of safety scandals in China and internationally. This article will present several of the recent key regulatory changes that regulatory and business professionals must be aware of when working to get their products marketed in China.
• Pharmaceuticals in India: A Business and Regulatory Outlook
  By Ames Gross and John Minot
  India has a federal form of government, and the medical regulatory structure is divided between national and state authorities. The principal national drug authority in New Delhi is the Central Drug Standards Control Organization (CDSCO). CDSCO is often referred to as the DCGI, which stands for Drug Controller General India, the title of its head official. There are also 35 state-level Food and Drug Administrations, one for each of India’s states and territories.
• Regulatory Strategy in Japan: How to Maximise your Chances of Success
  By Mohamed Oubihi
  It is still challenging for foreign pharma companies especially the new entrants to the Japanese market to navigate the murky waters of the regulatory environment and manage the intricacies of Japanese cultural barriers. This article introduces some of the unique aspects of Japanese regulatory requirements pertinent to CMC issues and highlights some of the cultural aspects that have a deep impact on success of your business in Japan.
• Embracing eCTDs and Electronic Submissions
  Pharma IQ
  While the electronic common technical document (eCTD) has grown to be a particularly accepted way for such information to be passed on, other submission styles are also used by a range of organisations. Figures from software provider Liquent have suggested that the idea of passing on such data digitally is being increasingly accepted by those involved in life sciences.

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