TERMIUM Plus®
The Government of Canada’s terminology and linguistic data bank.
THERAPEUTIC PRODUCTS PROGRAMME GUIDELINES [6 records]
Record 1 - internal organization data 2012-05-31
Record 1, English
Record 1, Subject field(s)
- Federal Government Bodies and Committees (Canadian)
- Medication
- Hygiene and Health
- Pharmaceutical Manufacturing
Record 1, Main entry term, English
- Therapeutic Products Classification Committee
1, record 1, English, Therapeutic%20Products%20Classification%20Committee
correct
Record 1, Abbreviations, English
- TPCC 2, record 1, English, TPCC
unofficial
Record 1, Synonyms, English
Record 1, Textual support, English
Record number: 1, Textual support number: 1 OBS
Health Canada. Therapeutic Products Classification Committee is a committee appointed by the Director General of the Programme to develop, maintain, evaluate and recommend for approval policies, procedures and guidelines concerning the classification and review of therapeutic products as drugs, devices or combination products; to assess submissions for combination products referred to it and determine an appropriate classification and review mechanism for the submission. 1, record 1, English, - Therapeutic%20Products%20Classification%20Committee
Record number: 1, Textual support number: 2 OBS
The acronym TPCC is used, but not official. 2, record 1, English, - Therapeutic%20Products%20Classification%20Committee
Record 1, French
Record 1, Domaine(s)
- Organismes et comités fédéraux (Gouvernement canadien)
- Médicaments
- Hygiène et santé
- Fabrication des produits pharmaceutiques
Record 1, Main entry term, French
- Comité de classification des produits thérapeutiques
1, record 1, French, Comit%C3%A9%20de%20classification%20des%20produits%20th%C3%A9rapeutiques
correct, masculine noun
Record 1, Abbreviations, French
- CCPT 2, record 1, French, CCPT
unofficial, masculine noun
Record 1, Synonyms, French
Record 1, Textual support, French
Record number: 1, Textual support number: 1 OBS
Santé Canada. Le Comité de classification des produits thérapeutiques est constitué par le directeur général du Programme pour élaborer, gérer et évaluer des politiques, procédures et lignes directrices relatives à la classification et à l'examen de produits thérapeutiques en tant que médicaments, matériels médicaux ou produits mixtes, et en recommander l'approbation, ainsi que pour évaluer les présentations de produits mixtes qui lui sont soumises et déterminer la classification et le mécanisme d'examen qui conviennent. 1, record 1, French, - Comit%C3%A9%20de%20classification%20des%20produits%20th%C3%A9rapeutiques
Record number: 1, Textual support number: 2 OBS
Bien que l'acronyme CCPT soit utilisé, il n'est pas officiel. 2, record 1, French, - Comit%C3%A9%20de%20classification%20des%20produits%20th%C3%A9rapeutiques
Record 1, Spanish
Record 1, Textual support, Spanish
Record 2 - internal organization data 2004-01-30
Record 2, English
Record 2, Subject field(s)
- Titles of Monographs
- Pharmacology
Record 2, Main entry term, English
- Disinfectant drugs
1, record 2, English, Disinfectant%20drugs
correct, Canada
Record 2, Abbreviations, English
Record 2, Synonyms, English
Record 2, Textual support, English
Record number: 2, Textual support number: 1 OBS
Health Canada, Drugs Directorate, Therapeutic Products Programme guidelines, Ottawa, 1999, ii, 83 pages. 1, record 2, English, - Disinfectant%20drugs
Record 2, French
Record 2, Domaine(s)
- Titres de monographies
- Pharmacologie
Record 2, Main entry term, French
- Désinfectants assimilés aux drogues
1, record 2, French, D%C3%A9sinfectants%20assimil%C3%A9s%20aux%20drogues
correct, masculine noun, plural, Canada
Record 2, Abbreviations, French
Record 2, Synonyms, French
Record 2, Textual support, French
Record number: 2, Textual support number: 1 OBS
Santé Canada, Direction des médicaments, Programme des produits thérapeutiques : ligne directrice, Ottawa, 1999, ii, 86 pages. 1, record 2, French, - D%C3%A9sinfectants%20assimil%C3%A9s%20aux%20drogues
Record 2, Spanish
Record 2, Textual support, Spanish
Record 3 - internal organization data 2001-09-19
Record 3, English
Record 3, Subject field(s)
- Titles of Monographs
- Pharmacology
Record 3, Main entry term, English
- Addendum to "Dose selection for carcinogenicity studies of pharmaceuticals": addition of a limit dose and related notes
1, record 3, English, Addendum%20to%20%5C%22Dose%20selection%20for%20carcinogenicity%20studies%20of%20pharmaceuticals%5C%22%3A%20addition%20of%20a%20limit%20dose%20and%20related%20notes
correct, Canada
Record 3, Abbreviations, English
Record 3, Synonyms, English
Record 3, Textual support, English
Record number: 3, Textual support number: 1 OBS
Health Canada, Health Products and Food Branch, Therapeutic Products Programme Guidelines Document ICH topic S1C(R), Ottawa, 2000, 2 pages. 2, record 3, English, - Addendum%20to%20%5C%22Dose%20selection%20for%20carcinogenicity%20studies%20of%20pharmaceuticals%5C%22%3A%20addition%20of%20a%20limit%20dose%20and%20related%20notes
Record number: 3, Textual support number: 2 OBS
ICH : International Conference on Harmonisation of Technical Requirements for Registration for Pharmaceuticals. 2, record 3, English, - Addendum%20to%20%5C%22Dose%20selection%20for%20carcinogenicity%20studies%20of%20pharmaceuticals%5C%22%3A%20addition%20of%20a%20limit%20dose%20and%20related%20notes
Record 3, Key term(s)
- Addendum to "Dose selection for carcinogenicity studies of pharmaceuticals"
Record 3, French
Record 3, Domaine(s)
- Titres de monographies
- Pharmacologie
Record 3, Main entry term, French
- Annexe à «sélection des doses pour les études de carcinogénicité de produits pharmaceutiques» : ajout d'une dose limite avec remarques
1, record 3, French, Annexe%20%C3%A0%20%C2%ABs%C3%A9lection%20des%20doses%20pour%20les%20%C3%A9tudes%20de%20carcinog%C3%A9nicit%C3%A9%20de%20produits%20pharmaceutiques%C2%BB%20%3A%20ajout%20d%27une%20dose%20limite%20avec%20remarques
correct, Canada
Record 3, Abbreviations, French
Record 3, Synonyms, French
Record 3, Textual support, French
Record number: 3, Textual support number: 1 OBS
Santé Canada, Direction générale des produits de santé et des aliments, document ICH thème S1C(R) des Directives du Programme des produits thérapeutiques, Ottawa, 2000, 2 pages. 2, record 3, French, - Annexe%20%C3%A0%20%C2%ABs%C3%A9lection%20des%20doses%20pour%20les%20%C3%A9tudes%20de%20carcinog%C3%A9nicit%C3%A9%20de%20produits%20pharmaceutiques%C2%BB%20%3A%20ajout%20d%27une%20dose%20limite%20avec%20remarques
Record number: 3, Textual support number: 2 OBS
ICH : Conférence internationale sur l'harmonisation des exigences techniques pour l'enregistrement des médicaments à usage humain. 2, record 3, French, - Annexe%20%C3%A0%20%C2%ABs%C3%A9lection%20des%20doses%20pour%20les%20%C3%A9tudes%20de%20carcinog%C3%A9nicit%C3%A9%20de%20produits%20pharmaceutiques%C2%BB%20%3A%20ajout%20d%27une%20dose%20limite%20avec%20remarques
Record 3, Key term(s)
- Annexe à «sélection des doses pour les études de carcinogénicité de produits pharmaceutiques»
Record 3, Spanish
Record 3, Textual support, Spanish
Record 4 - internal organization data 2001-09-19
Record 4, English
Record 4, Subject field(s)
- Titles of Monographs
- Toxicology
- Pharmacology
Record 4, Main entry term, English
- Genotoxicity: a standard battery for genotoxicity testing of pharmaceuticals
1, record 4, English, Genotoxicity%3A%20a%20standard%20battery%20for%20genotoxicity%20testing%20of%20pharmaceuticals
correct, Canada
Record 4, Abbreviations, English
Record 4, Synonyms, English
Record 4, Textual support, English
Record number: 4, Textual support number: 1 OBS
Health Canada, Health Products and Food Branch, Therapeutic Products Programme Guidelines Document ICH topic S2B, Ottawa, 2000, 9 pages. 2, record 4, English, - Genotoxicity%3A%20a%20standard%20battery%20for%20genotoxicity%20testing%20of%20pharmaceuticals
Record number: 4, Textual support number: 2 OBS
ICH: International Conference on Harmonisation of Technical Requirements for Registration for Pharmaceuticals. 2, record 4, English, - Genotoxicity%3A%20a%20standard%20battery%20for%20genotoxicity%20testing%20of%20pharmaceuticals
Record 4, French
Record 4, Domaine(s)
- Titres de monographies
- Toxicologie
- Pharmacologie
Record 4, Main entry term, French
- Génotoxicité : batterie d'épreuves normalisées pour l'évaluation de la génotoxicité des produits pharmaceutiques
1, record 4, French, G%C3%A9notoxicit%C3%A9%20%3A%20batterie%20d%27%C3%A9preuves%20normalis%C3%A9es%20pour%20l%27%C3%A9valuation%20de%20la%20g%C3%A9notoxicit%C3%A9%20des%20produits%20pharmaceutiques
correct, Canada
Record 4, Abbreviations, French
Record 4, Synonyms, French
Record 4, Textual support, French
Record number: 4, Textual support number: 1 OBS
Santé Canada, Direction générale des produits de santé et des aliments, document ICH thème S2B des Directives du Programme des produits thérapeutiques, Ottawa, 2000, 11 pages. 2, record 4, French, - G%C3%A9notoxicit%C3%A9%20%3A%20batterie%20d%27%C3%A9preuves%20normalis%C3%A9es%20pour%20l%27%C3%A9valuation%20de%20la%20g%C3%A9notoxicit%C3%A9%20des%20produits%20pharmaceutiques
Record number: 4, Textual support number: 2 OBS
ICH : Conférence internationale sur l'harmonisation des exigences techniques pour l'enregistrement des médicaments à usage humain. 2, record 4, French, - G%C3%A9notoxicit%C3%A9%20%3A%20batterie%20d%27%C3%A9preuves%20normalis%C3%A9es%20pour%20l%27%C3%A9valuation%20de%20la%20g%C3%A9notoxicit%C3%A9%20des%20produits%20pharmaceutiques
Record 4, Spanish
Record 4, Textual support, Spanish
Record 5 - internal organization data 2001-09-19
Record 5, English
Record 5, Subject field(s)
- Titles of Monographs
- Toxicology
Record 5, Main entry term, English
- Duration of chronic toxicity testing in animals (rodent and non rodent toxicity testing)
1, record 5, English, Duration%20of%20chronic%20toxicity%20testing%20in%20animals%20%28rodent%20and%20non%20rodent%20toxicity%20testing%29
correct, Canada
Record 5, Abbreviations, English
Record 5, Synonyms, English
Record 5, Textual support, English
Record number: 5, Textual support number: 1 OBS
Health Canada, Health Products and Food Branch, Therapeutic Products Programme Guidelines Document ICH topic S4A, Ottawa, 2000, 2 pages. 2, record 5, English, - Duration%20of%20chronic%20toxicity%20testing%20in%20animals%20%28rodent%20and%20non%20rodent%20toxicity%20testing%29
Record number: 5, Textual support number: 2 OBS
ICH: International Conference on Harmonisation of Technical Requirements for Registration for Pharmaceuticals. 2, record 5, English, - Duration%20of%20chronic%20toxicity%20testing%20in%20animals%20%28rodent%20and%20non%20rodent%20toxicity%20testing%29
Record 5, French
Record 5, Domaine(s)
- Titres de monographies
- Toxicologie
Record 5, Main entry term, French
- Durée des essais de toxicité chronique chez les animaux (essais de toxicité chez les rongeurs et les autres animaux)
1, record 5, French, Dur%C3%A9e%20des%20essais%20de%20toxicit%C3%A9%20chronique%20chez%20les%20animaux%20%28essais%20de%20toxicit%C3%A9%20chez%20les%20rongeurs%20et%20les%20autres%20animaux%29
correct, Canada
Record 5, Abbreviations, French
Record 5, Synonyms, French
Record 5, Textual support, French
Record number: 5, Textual support number: 1 OBS
Santé Canada, Direction générale des produits de santé et des aliments, document ICH thème S4A des Directives du Programme des produits thérapeutiques, Ottawa, 2000, 2 pages. 2, record 5, French, - Dur%C3%A9e%20des%20essais%20de%20toxicit%C3%A9%20chronique%20chez%20les%20animaux%20%28essais%20de%20toxicit%C3%A9%20chez%20les%20rongeurs%20et%20les%20autres%20animaux%29
Record number: 5, Textual support number: 2 OBS
ICH : Conférence internationale sur l'harmonisation des exigences techniques pour l'enregistrement des médicaments à usage humain. 2, record 5, French, - Dur%C3%A9e%20des%20essais%20de%20toxicit%C3%A9%20chronique%20chez%20les%20animaux%20%28essais%20de%20toxicit%C3%A9%20chez%20les%20rongeurs%20et%20les%20autres%20animaux%29
Record 5, Spanish
Record 5, Textual support, Spanish
Record 6 - internal organization data 2001-09-19
Record 6, English
Record 6, Subject field(s)
- Titles of Monographs
- Pharmacology
Record 6, Main entry term, English
- Testing for Carcinogenicity of Pharmaceuticals
1, record 6, English, Testing%20for%20Carcinogenicity%20of%20Pharmaceuticals
correct, Canada
Record 6, Abbreviations, English
Record 6, Synonyms, English
Record 6, Textual support, English
Record number: 6, Textual support number: 1 OBS
Health Canada, Health Products and Food Branch, Therapeutic Products Programme Guidelines Document ICH topic S1B, Ottawa, 2000, 9 pages. 2, record 6, English, - Testing%20for%20Carcinogenicity%20of%20Pharmaceuticals
Record number: 6, Textual support number: 2 OBS
ICH: International Conference on Harmonisation or Technical Requirements for Registration of Pharmaceuticals for Human Use. 2, record 6, English, - Testing%20for%20Carcinogenicity%20of%20Pharmaceuticals
Record 6, French
Record 6, Domaine(s)
- Titres de monographies
- Pharmacologie
Record 6, Main entry term, French
- Évaluation de la cancérogénicité des produits pharmaceutiques
1, record 6, French, %C3%89valuation%20de%20la%20canc%C3%A9rog%C3%A9nicit%C3%A9%20des%20produits%20pharmaceutiques
correct, Canada
Record 6, Abbreviations, French
Record 6, Synonyms, French
Record 6, Textual support, French
Record number: 6, Textual support number: 1 OBS
Santé Canada, Direction générale des produits de santé et des aliments, document ICH thème S1B des Directives du Programme des produits thérapeutiques, Ottawa, 2000, 10 pages. 1, record 6, French, - %C3%89valuation%20de%20la%20canc%C3%A9rog%C3%A9nicit%C3%A9%20des%20produits%20pharmaceutiques
Record number: 6, Textual support number: 2 OBS
ICH : Conférence internationale sur l'harmonisation des exigences techniques pour l'enregistrement des médicaments à usage humain. 2, record 6, French, - %C3%89valuation%20de%20la%20canc%C3%A9rog%C3%A9nicit%C3%A9%20des%20produits%20pharmaceutiques
Record 6, Spanish
Record 6, Textual support, Spanish
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