International comparison of assessments of pharmaceutical innovation

Health Policy

Volumn 105, Issue 2-3, 2012, Pages 221-225

  Lexchin, Joel ^a,b,c  

^a YORK UNIVERSITY   (Canada)

^b UNIVERSITY HEALTH NETWORK   (Canada)

^c UNIVERSITY OF TORONTO   (Canada)

Author keywords

Canada; Drug regulation; Review status; Therapeutic innovation

Indexed keywords

ARTICLE; CANADA; CLINICAL ASSESSMENT; CLINICAL DECISION MAKING; CONTROLLED STUDY; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG SCREENING; FOOD AND DRUG ADMINISTRATION; HEALTH CARE ORGANIZATION; HEALTH CARE POLICY; HUMAN; HUMAN DRUG ADVISORY PANEL; INTERNATIONAL COOPERATION; MEDICINE; PEER REVIEW; THERAPEUTIC PRODUCTS DIRECTORATE;

CANADA; DRUGS, INVESTIGATIONAL; GOVERNMENT AGENCIES; HEALTH POLICY; HUMANS; THERAPIES, INVESTIGATIONAL; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84859755554     PISSN: 01688510     EISSN: 18726054     Source Type: Journal    
DOI: 10.1016/j.healthpol.2012.02.005     Document Type: Article

References (15)

1. International Society of Drug Bulletins ISDB declaration on therapeutic advance in the use of medicines 2001, ISDB, Paris.
2. Health Canada Notice of compliance (NOC) database terminology 2010, Health Canada, Ottawa.
3. Patented Medicine Prices Review Board Compendium of guidelines, policies and procedures 2011, PMPRB, Ottawa.
4. Ahlqvist-Rastad J., Bardelay D., Beermann B., Mignot G. Judging the therapeutic value of drugs: a comparison between La revue Prescrire and Information från Läkemedelsverket, the bulletin of the Swedish Medical Products Agency. International Journal of Risk & Safety in Medicine 2004, 16:83-90.
5. Trotta F., Leufkens H.G.M., Schellens J.H.M., Laing R., Tafuri G. Evaluation of oncology drugs at the European Medicines Agency and US Food and Drug Administration: when differences have an impact on clinical practice. Journal of Clinical Oncology 2011, 29:2266-2272.
6. Health Canada Notice of compliance with conditions (NOC/c) 2002, Health Canada, Ottawa.
7. U.S. Food and Drug Administration Fast track, accelerated approval and priority review: accelerating availability of new drugs for patients with serious diseases 2010, U.S. Department of Health & Human Services.
8. U.S. Food and Drug Administration NME drug and new biologic approvals 2011, U.S. Department of Health & Human Services.
9. ANON. A look back at 2009: one step forward, two steps back. Prescrire International 2010;30:136-42.
10. Landis J.R., Koch G.G. The measurement of observer agreement for categorical data. Biometrics 1977, 33:159-174.
11. Motola D., De Ponti F., Rossi P., Martini N., Montanaro N. Therapeutic innovation in the European Union: analysis of the drugs approved by the EMEA between 1995 and 2003. British Journal of Clinical Pharmacology 2004, 59:475-478.
12. Garattini S., Bertele V. Efficacy, safety, and cost of new anticancer drugs. BMJ 2002, 325:269-271.
13. Joppi R., Bertele V., Garattini S. Disappointing biotech. BMJ 2005, 331:895-897.
14. Lexchin J. Marketing before patenting: implications for price controls in Canada. Open Medicine 2010, 4:E139-E142.
15. Pharmaceutical Research and Manufacturers of America innovation.org: discovering new medicines for better lives and a brighter future. Incremental innovation 2011, PhRMA.