Regulatory & Clinical Trials

(As usual, in progress)

Bosnia

ALIMBIH — Agencija za lijekove i medicinska sredstva Bosne i Hercegovine: http://www.almbih.gov.ba/o-nama/

ALIMBIH Link Page: Links to BiH Ministries, Regulatory agencies of European countries

Banja Luka Clinical Center — About Us

Banja Luka Clinical Center — Ethics Committee Standard Procedure (PDF)

Croatia

HALMED — Agencija za lijekove i medicinske proizvode: http://www.almp.hr/

Central Ethics Committee (Institutional Review Board): http://www.almp.hr/?ln=en&w=o_SEPu

http://www.klinickaispitivanja.hr/ — Stranica je izrađena pod pokroviteljstvom Hrvatske udruge inovativnih proizvođača lijekova. Potporu projektu dali su: Središnje etičko povjerenstvo pri Agenciji za
lijekove i medicinske proizvode, Hrvatsko društvo za kliničku farmakologiju i terapiju Hrvatskoga liječničkog zbora i Koalicija udruga u zdravstvu.

http://www.klinickaispitivanja.hr/en — The website was sponsored by the Croatian Association of Research-based Pharmaceutical Companies. The project was supported by: Central Ethics Committee within the Agency for Medicinal Products and Medical Devices, Croatian Society for Clinical Pharmacology and Therapy of the Croatian Medical Association and Coalition of Associations in Healthcare.

Serbia

http://www.alims.gov.rs/latin/

http://www.alims.gov.rs/eng/

Europe

EMA — European Medicines Agency: http://www.ema.europa.eu/ema/

EMA Regulatory and Procedural Guidance Index

EMA Product Information Templates

EDQM — European Directorate for the Quality of Medicines and Healthcare: http://www.edqm.eu/site/EDQM-structure-660.html

EDQM Document download page

https://www.clinicaltrialsregister.eu

European Commission – EudraLex: http://ec.europa.eu/health/documents/eudralex/index_en.htm This page contains links not only to relevant legislation, but also to “The rules governing medicinal products in the European Union.” All the forms are here, all the procedures described — a treasure trove of terminology.

Cross-posted with Style: The European Commission Directorate-General for Translation’s English Style Guide: A handbook for authors and translators in the European Commission
http://ec.europa.eu/translation/english/guidelines/documents/styleguide_english_dgt_en.pdf

UK

MHRA — Medicines and Healthcare Products Regulatory Agency: http://www.mhra.gov.uk/

MHRA — How We Regulate: http://www.mhra.gov.uk/Howweregulate/index.htm

USA

http://clinicaltrials.gov/ct2/home

FDA — U.S. Food and Drug Administration: http://www.fda.gov/

FDA — Drug Development and Approval Process

FDA Glossary: http://www.fda.gov/Drugs/InformationOnDrugs/ucm079436.htm

International

IMDRF — International Medical Device Regulators Forum: http://www.imdrf.org/index.asp

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