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[Regulatory control of new medicines: help or hindrance?].
Praxis (Bern 1994). 1999 Apr 15; 88(16):701-8.P

Abstract

To answer the question of the benefit and the cost/benefit ratio of the activities of a drug regulatory agency, the most important, clinically relevant "products" of a licensing authority in general, and the Swiss licensing authority (IKS) in particular are discussed. The activities of the medicines licensing authority assure that: For all new substances the efficacy and a positive benefit/risk ratio have been demonstrated before a marketing authorisation. For all marketed medicines an information for professionals and patients is available that has been evaluated and approved by an independent and competent reviewer. An independent post marketing surveillance of the side effects profile continues after a medicine has been put on the market. All clinical trials investigating medicinal products are performed according to GCP rules corresponding to international ethical and scientific standards. An international comparison of the time needed for the evaluation of a marketing authorisation application for a new medicine reveals that the IKS is one of the most efficient agencies. This is illustrated with an example showing the evaluation times of the EMEA and the IKS for products approved in 1997.

Authors+Show Affiliations

Interkantonale Kontrollstelle für Heilmittel (IKS), Bern.

Pub Type(s)

English Abstract
Journal Article
Review

Language

ger

PubMed ID

10355335

Citation

Vozeh, S. "[Regulatory Control of New Medicines: Help or Hindrance?]." Praxis, vol. 88, no. 16, 1999, pp. 701-8.
Vozeh S. [Regulatory control of new medicines: help or hindrance?]. Praxis (Bern 1994). 1999;88(16):701-8.
Vozeh, S. (1999). [Regulatory control of new medicines: help or hindrance?]. Praxis, 88(16), 701-8.
Vozeh S. [Regulatory Control of New Medicines: Help or Hindrance?]. Praxis (Bern 1994). 1999 Apr 15;88(16):701-8. PubMed PMID: 10355335.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - [Regulatory control of new medicines: help or hindrance?]. A1 - Vozeh,S, PY - 1999/6/4/pubmed PY - 1999/6/4/medline PY - 1999/6/4/entrez SP - 701 EP - 8 JF - Praxis JO - Praxis (Bern 1994) VL - 88 IS - 16 N2 - To answer the question of the benefit and the cost/benefit ratio of the activities of a drug regulatory agency, the most important, clinically relevant "products" of a licensing authority in general, and the Swiss licensing authority (IKS) in particular are discussed. The activities of the medicines licensing authority assure that: For all new substances the efficacy and a positive benefit/risk ratio have been demonstrated before a marketing authorisation. For all marketed medicines an information for professionals and patients is available that has been evaluated and approved by an independent and competent reviewer. An independent post marketing surveillance of the side effects profile continues after a medicine has been put on the market. All clinical trials investigating medicinal products are performed according to GCP rules corresponding to international ethical and scientific standards. An international comparison of the time needed for the evaluation of a marketing authorisation application for a new medicine reveals that the IKS is one of the most efficient agencies. This is illustrated with an example showing the evaluation times of the EMEA and the IKS for products approved in 1997. SN - 1661-8157 UR - https://www.unboundmedicine.com/medline/citation/10355335/[Regulatory_control_of_new_medicines:_help_or_hindrance]_ L2 - https://medlineplus.gov/drugsafety.html DB - PRIME DP - Unbound Medicine ER -
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