Proceedings of the Eighth International Conference of Drug Regulatory Authorities (ICDRA) - Bahrain, 10-13 November 1996: Tripartite harmonization - International Conference on Harmonization (ICH): Viewpoint of a regulator from a non-ICH country: safety

Proceedings of the Eighth International Conference of Drug Regulatory Authorities (ICDRA) - Bahrain, 10-13 November 1996
(1996; 111 pages)

Table of Contents

	Opening ceremony
		Welcome speech by His Excellency Dr Faisal Al-Mousawi, Minister of Health, State of Bahrain
		Opening speech by Dr Hiroshi Nakajima, Director-General, World Health Organization
		Address by Dr Hussein A. Gezairy, Regional Director, WHO Eastern Mediterranean Region
	International harmonization of regulatory requirements Plenary: 10 November 1996
		Introduction - Dr S. Nightingale, United States of America
	Global harmonization
		WHO and regulatory harmonization for pharmaceuticals - Dr. Idänpään-Heikkilä, WHO
	Tripartite harmonization - International Conference on Harmonization (ICH)
		Structure and working methods of the International Conference on Harmonization (ICH) - Margaret Cone, International Federation of Pharmaceutical Manufacturers Associations (IFPMA)
		Statement from ICH 3 - Dr O. Doi, Japan
		Viewpoint of an industry representative from a non-ICH country: quality - Professor Mamdouh A. Razik Moustafa, Egypt
		Viewpoint of a regulator from a non-ICH country: safety - Professor L. Rägo, Estonia
		Progress report from the ICH working group on efficacy - Professor C. Naito, Japan
		ICH efficacy documents - a non-ICH country view - Dr J. McEwen, Australia
	Regional harmonization activities
		The new European marketing authorization system - Mr F. Sauer, European Agency for the Evaluation of Medicinal Products (EMEA)
		Regional harmonization in the Americas - Dr E. Fefer, WHO/AMRO
	Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)
		The implications of the TRIPS agreement for the protection of pharmaceutical Inventions - Adrian Otten, World Trade Organization
		Effect of WTO agreements on pharmaceutical trade in Arab countries - Mr M. Jafar Redha, Bahrain
		Closing remarks - Dr S. Nightingale, United States of America
		Recommendations
	The mission of drug regulatory authorities
		The importance of the mission - Dr A.W. Broekmans, Netherlands
		Regulatory control In a changing environment - Dr E. Fefer, WHO/AMRO
		Financing of a drug regulatory authority and user fees - Ms Layla Abdul-Rahman, Bahrain
		Structure and financing of a drug regulatory authority - Dr T. Tominaga, Japan
		Structure and financing of a drug regulatory authority - Dr M.N. Dauramanzi, Zimbabwe
		Discussion group conclusions
		Recommendations
	Counterfeit drugs
		Combating counterfeiters - Dr K. Jones, United Kingdom
		Counterfeit medicines: a special case for concern - Margaret Cone, IFPMA
		Country studies on counterfeit drugs - Mr Eshetu Wondemagegnehu, DAP/WHO
		WHO guidelines to combat counterfeit drugs - Professor T. Paal, Hungary
		Rapid detection of counterfeit drags using simple tests - Dr S. Mizuno, Japan
		WHO data base on counterfeit medicines - Dr K. Kimura, WHO
		Recommendations
	Computer-assisted drug registration
		Introduction - Professor A. Toumi, Tunisia
		Description of the software package - Dr V. Reggi, WHO
		Country experience in computerized registration - Dr E. Kriel, South Africa
		Country experience in computerized registration - Mr B.K. Khakurel, Nepal
		Country experience in computerized registration - Professor A. Quintana, Venezuela
		Recommendations
	Updates
		Use and future of the International Pharmacopoeia - Professor T. Paal, Hungary
		Drug donations: the Eritrean experience - Kidane Woldeyesus
		Report on diethylene glycol poisoning in Haiti - Dr E. Fefer, WHO/AMRO
		Regulatory measures to allow timely provision of controlled medicines in emergency situations - Mr T. Yoshida, WHO
		Recommendation
	The challenge of biotechnology
		Introduction - Dr E. Griffiths, WHO
		Regulatory experience in countries with an evolving biotechnology industry - Dr C. Sanchez, Cuba
		Regulatory experience In countries with an evolving biotechnology industry - Dr T. Bektimirov, Russia
		Regulatory experience in Importing countries - Dr Mahmood Dada, Saudi Arabia
		Regulatory experience In Importing countries - Dr B. Njue, Kenya
		Regional initiative for vaccine quality assurance - Dr A. Saleh, WHO/EMRO
		Current quality control Issues: cell substrates used for the production of biologicals - Dr T. Hayakawa, Japan
		Recommendations
	Pharmacovigilance
		Introduction - Dr M. ten Ham, WHO
		Monitoring of adverse drug reactions - Professor E. Gabrielian, Armenia
		Monitoring of adverse drug reactions - Dr J. McEwen, Australia
		Monitoring of adverse drug reactions - Dr P. Folb, South Africa
		Monitoring of adverse drug reactions - Dr E. Kkolos, Cyprus
		Recommendations
	WHO Certification scheme: current developments
		How to improve implementation of the Scheme in a developed country - Mr H. Smallenbroek, Netherlands
		Certification of pharmaceutical substances - Mr H. Ikäläinen, Finland - Chairman of Pharmaceutical Inspection Convention (PIC)
	Regulatory control and assessment of herbal medicines
		WHO'S activities - Dr X. Zhang, WHO
		WHO monographs on selected medicinal plants - Dr Konstantin Keller, Germany
		Herbal medicines: country situation - Mr A. Chan, Hong Kong
		Herbal medicines: country situation - Mrs Tan Shook Fong, Singapore
		Recommendations
	Registration requirements for multisource products (generics)
		Use of standardized marketing authorization - Professor A. Hildebrandt, Germany
		Requirements for dissolution tests and need for in vivo bioequivalence studies - Dr R. Williams, United States of America
		Evaluation and registration requirements for individual multisource (generic) pharmaceutical products - E.C.M. Santero, Philippines
		Recommendations
	List of participants

Viewpoint of a regulator from a non-ICH country: safety - Professor L. Rägo, Estonia

The ICH guidelines are undoubtedly of value, but are dedicated to specific topics rather than reflecting a comprehensive picture of the whole area. For small drug regulatory authorities it is vital not to get lost in details and to focus on priorities. The ICH guidelines are therefore not vital to our regulatory structure and they should be evaluated at national level with regard to their relevance and implemented according to the needs of the country.

One important aim for my own country is to bring legislation in line with that of the European Union. For this reason, the ICH guidelines are considered important. However, we are often not in a position to comment on the voluminous draft ICH texts with intricate technical details which we receive given the limited resources of our regulatory authority. On the other hand it is true that the ICH documents contain technical and scientific information which is valuable in improving the professional knowledge of regulators

In considering the ICH safety guidelines, it is apparent that they are of practical value and, for example in the case of carcinogenicity studies, will allow the regulator to evaluate whether studies should be required in the approval process. More specifically, we have found that the guideline on the assessment of systemic exposure is too general in its advice. Only limited practical value can be accorded to the guidance for repeated dose tissue distribution studies although it may have educational value as it covers a very specific area of expertise. The guidelines on the detection of toxicity to reproduction for medicinal products and toxicity to male fertility together form valuable material. But for the time being, this value is educational rather than regulatory, and the document would seem to have more importance for the pharmaceutical industry. Concerning wider dissemination, I would like to know whether the guidelines under discussion could be made available on the Internet and whether a server group could be established for comments and feedback?

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