Where is industry getting it wrong? A review of quality concerns raised at day 120 by the committee for medicinal products for human use during European centralised marketing authorisation submissions for chemical entity medicinal products

Journal of Pharmacy and Pharmaceutical Sciences

Volumn 12, Issue 2, 2009, Pages 181-198

  Borg, John Joseph ^a,c   Robert, Jean Louis ^b,c   Wade, George ^c   Aislaitner, George ^c,d   Pirozynski, Michal ^c,e   Abadie, Eric ^c,f   Salmonson, Tomas ^c,g   Bonanno, Patricia Vella ^a,c  

^a Medicines Authority   (Malta)

^b LABORATOIRE NATIONAL DE SANTÉ   (Luxembourg)

^c EUROPEAN MEDICINES AGENCY   (United Kingdom)

^d National Organization for Medicines (EOF)   (Greece)

^e MEDICAL UNIVERSITY OF WARSAW   (Poland)

^f AFSSAPS   (France)

^g MEDICAL PRODUCTS AGENCY   (Sweden)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG;

ARTICLE; CENTRALIZATION; DRUG CONTROL; DRUG FORMULARY; DRUG INDUSTRY; DRUG INFORMATION; DRUG MANUFACTURE; DRUG MARKETING; DRUG QUALITY; DRUG SCREENING; DRUG USE; EUROPEAN UNION; NATIONAL HEALTH ORGANIZATION; TREND STUDY; DRUG APPROVAL; DRUG LEGISLATION; EUROPE; FACTUAL DATABASE; HUMAN; LEGAL ASPECT; MARKETING; ORGANIZATION AND MANAGEMENT;

DATABASES, FACTUAL; DRUG APPROVAL; DRUG INDUSTRY; EUROPE; EUROPEAN UNION; HUMANS; LEGISLATION, DRUG; MARKETING; PHARMACEUTICAL PREPARATIONS;

EID: 70349319551     PISSN: None     EISSN: 14821826     Source Type: Journal    
DOI: 10.18433/j3fw2q     Document Type: Article

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