Proceedings of the Tenth International Conference of Drug Regulatory Authorities (ICDRA) - Hong Kong, China, 24 - 27 June 2002: Regulatory challenges: health sector reform and drug regulatory capacity

Proceedings of the Tenth International Conference of Drug Regulatory Authorities (ICDRA) - Hong Kong, China, 24 - 27 June 2002
(2002; 166 pages)

Table of Contents

	Abbreviations and acronyms used in this report
	Opening ceremony
		Mr Xiaoyu Zheng, Director-General, State Drug Administration, China
		Dr Yasuhiro Suzuki, Executive Director, Health Technology and Pharmaceuticals, World Health Organization, Geneva, Switzerland
		Dr Eng-Kiong Yeoh, Secretary for Health and Welfare, Hong Kong Special Administrative Region, China
		Professor Alfred Hildebrandt, Chair of the Ninth ICDRA, Germany
		Dr Margaret Chan, Chair of the Tenth ICDRA Director of Health, Hong Kong Special Administrative Region, China
	Herbal medicines
		Current status of traditional Chinese medicines in China
		Regulation of traditional Chinese medicines in Hong Kong, China
		Proposed regulations for natural health products in Canada
		How regulation of herbal medicines was established in Thailand
		Herbal medicine in the Islamic Republic of Iran
		Traditional herbal medicines: an update on European Union activities
		Regulation of herbal medicines in Ghana
		Recommendations
	Keynote address
		Access to essential drugs and vaccines: the role of regulators
	Safety of blood-derived products
		Quality and safety of plasma for fractionation
		Procedures for inactivation and removal of viruses
		GMP in blood plasma collection centres
		Plasma fractionation - Brazilian programme of self-sufficiency in blood products
		Safety of blood products in New Zealand
		Regulatory experience in Argentina
		Safety of blood products in the Islamic Republic of Iran
		Recommendations
	Antimicrobial resistance - new initiatives
		WHO’s global strategy for the containment of antimicrobial resistance
		Implementing a strategy for the containment of antimicrobial resistance: experience in Uganda
		Veterinary issues contributing to antimicrobial resistance
		Status of regulation of antimicrobials in Cuba
		Fighting antibiotic resistance in Sweden
		Antimicrobial use in Chile - the impact of regulatory measures
		Recommendations
	Harmonization I
		The harmonization process of ICH
		European contribution to a global approach to regulation
		The harmonization process of ICH - philosophy, process and future
		Impact of ICH on non-ICH countries
		ICH - its value to a first-line medicines regulator
		Recommendations
	Harmonization II
		Regional harmonization initiatives - the Association of South-East Asian Nations (ASEAN)
		Harmonization in the Americas
		Centralized drug registration system in the Gulf Region
		Recommendations
	Protection of trial subjects in clinical trials
		Cross-border movement of clinical trial subjects
		Cross-border movement of clinical trial subjects and regulatory communication
		Ethical principles and protection of trial subjects in China
		Recommendations
	Regulating biotechnology products
		Comparability of biotechnology products and cell substrates
		Assessing biocomparability: a Canadian perspective
		Regulatory aspects of nucleic acid vaccines
		Report on WHO Monitoring Group on Gene Therapy
		Regulating biotechnology products: Cuban experience
		Regulation of products derived from recombinant DNA technology in China
		Regulation of biotechnology products in the Republic of Korea
		Regulation of biotechnology products in Indonesia
		Recommendations
	Regulatory challenges: health sector reform and drug regulatory capacity
		Strengthening regulatory capacity during reform
		The creation of a trans-Tasman therapeutic products regulatory agency: a case study in cooperation
		The South African experience
		Drug registration and importation control in Tunisia
		Health reform and drug regulation in Venezuela
		Economic regulation of pharmaceuticals in Brazil
		Recommendations
	Access to drugs and vaccines I
		Generic medicines: old problems and new challenges from a European perspective
		Access to quality pharmaceuticals: the Indian experience
		Quality of starting materials for drugs and vaccines
		Fixed-combination medicines: an Australian perspective
		Drugs for neglected diseases: challenges for regulators
		Recommendations
	Access to drugs and vaccines II
		Twenty-five years of essential medicines: progress and agenda for regulators
		Essential drugs list: South African experience
		The role of government and essential drugs - Indonesian experience
		Thailand’s experience in access to medicines
		Current vaccine shortages in the United States of America
		Expanding access to essential medicines and vaccines: lessons learnt in Brazil
		Recommendations
	Counterfeit pharmaceutical products
		Counterfeit pharmaceutical products
		The fight against counterfeit drugs in the Russian Federation
		Counterfeit medicines
		Recommendations
	Homoeopathy
		Registration criteria for homoeopathic medicinal products in the United Arab Emirates
		The regulatory framework for homoeopathic medicinal products in Germany and in the European Union
		Regulation of homoeopathic products in the United Kingdom
		Recommendations
	Safety monitoring
		The impact of regulation on the safe use of drugs: overview of the Workshop
		Sources of information for regulators
		Crisis, pressure and controversy
		Improving international drug monitoring
		Recommendations
	E-Commerce
		Drug promotion and sales through the Internet
		Medicines and the Internet - regulatory approaches in Singapore
		Pharmaceuticals and e-commerce: the Netherlands
		Recommendations
	Current topics
		“For export only” manufactured drugs and cosmetics that are not legally used in country of manufacture
		WHO Certification Scheme: input for implementation
		Value of joining the Pharmaceutical Inspection Cooperation Scheme (PIC/S) for developing countries: the Malaysian experience
		Pharmacopoeial specifications for new drug entities
		Improving the impact of drug regulatory authorities on public health
		Strengthening drug regulatory authorities in small Pacific Island nations
		Transparency of data
		Kava
		Xenotransplantation and xenotourism: time for concerted regulatory action
		Recommendations
	Regulatory challenges of new technologies
		The EU regulatory system in the international environment
		FDA/CBER regulation of emerging therapies
	List of participants
	Back cover

Regulatory challenges: health sector reform and drug regulatory capacity

Moderator: Dr Jorge Bermudez, Brazil

Regulatory control is a state and government responsibility. Within the pharmaceutical sector, regulation must take account of three essential aspects: public health, policy-making, and harmonization.