The value and benefits of the international conference on harmonisation to drug regulatory authorities: Advancing harmonization for better public health

Clinical Pharmacology and Therapeutics

Volumn 89, Issue 4, 2011, Pages 503-512

  Molzon, J A ^a   Giaquinto, A ^b   Lindstrom, L ^c   Tominaga, T ^d   Ward, M ^e   Doerr, P ^f   Hunt, L ^g   Rago, L ^h  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b PhRMa 1990 2003   (United States)

^c EUROPEAN COMMISSION   (Belgium)

^d PHARMACEUTICALS AND MEDICAL DEVICES AGENCY   (Japan)

^e HEALTH CANADA   (Canada)

^f Swissmedic   (Switzerland)

^g THERAPEUTIC GOODS ADMINISTRATION   (Australia)

^h WORLD HEALTH ORGANIZATION   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; FOOD AND DRUG ADMINISTRATION; GOOD CLINICAL PRACTICE; GOVERNMENT REGULATION; HEALTH CARE ORGANIZATION; INTERNATIONAL CONFERENCE ON HARMONISATION; PRACTICE GUIDELINE; PRIORITY JOURNAL; PUBLIC HEALTH; REGISTRATION;

CONGRESSES AS TOPIC; DRUG APPROVAL; EUROPE; GUIDELINES AS TOPIC; HUMANS; INTERNATIONAL COOPERATION; JAPAN; LEGISLATION, DRUG; UNITED STATES;

EID: 79952992151     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2011.10     Document Type: Article

References (7)

1. International Conference on Harmonisation. ICH Guidelines. http://www.Ich. Org/products/guidelines . Accessed 20 april 2010.
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3. Molzon, J. The value and benefits of the international conference on harmonization (iCH) to regulators. DIA Global Forum 2, 12-14 (2010).
4. Molzon, J. The common technical document: the changing face of the New Drug application. Nat. Rev. Drug Discov. 2, 71-74 (2003). (Pubitemid 37361626)
5. Molzon, J. The international Conference on Harmonization common technical document?global submission format? Food Drug Law J. 60, 447-452 (2005).
6. European Medicines agency. Procedure for European Union guidelines and related documents within the pharmaceutical legislative framework. EMEa/p/24143/2004. http://www.Ema.Europa.Eu/docs/en-GB/document-library/ Scientific-guideline/2009/10/WC500004011.Pdf. Accessed 3 June 2010.
7. Shah, R.R. & Raymond, A.S. (2009) Regulation of human medicinal products in the European Union. In The Textbook of Pharmaceutical Medicine, 6th edn (ed. Griffin, J.P.) 444-499 (Wiley-Blackwell, Oxford, UK).