미국, 유럽 등의 GMP 가이드라인에 대해서는 이전 포스팅에서 사이트/자료 검색 방법을 알아보았습니다. Canada의 경우도 사이트에서 원하는 GMP 문서 및 가이던스를 어떻게 찾는지 미리 알아 두면 좋겠네요.
Canada GMP
Guidance Documents
Applications and submissions
Drug products
영어가 부담스럽기는 하지만 미리미리 사이트를 방문하여 익혀 두어야 필요할 때 쉽게 찾을 수 있습니다. Canada GMP의 경우 평소에 마땅히 읽어 보거나 하지 않고 위치 정도만 알아두고 있습니다.
링크를 클릭해서 이동하면 아래와 같은 화면이 나타납니다.
혹시 링크가 잘 안 되시는 분들은 아래 순서에 따라 이동해 보시면 쉽게 원하는 곳을 찾을 수 있습니다.
Canada.ca >>>> Departments and agencies >>>> Health Canada >>>> Drugs and health products >>>> Drug products Applications and Submissions >>>> Drug Products
친절하게 A부터 순서대로 문서 링크가 정리되어 있습니다.
G로 이동해 보면 Good manufacturing practices guide for drug products (GUI-0001)을 찾을 수 있습니다.
첨부는 해 두었지만 언제 개정될지 모르니 사이트 방문하는 것을 습관화해 둡니다.
많은 문서가 잘 정리되어 있고 사이트가 매우 직관적이라 추가 설명도 필요 없을 정도입니다. 사이트 방문해서 바로 검색해보는 것이 가장 빠른 길입니다.
A
Acetaminophen Labelling Standard
Administrative Processing of Submissions and Applications Involving Human or Disinfectant Drugs
Adverse Reactions:
Reporting Adverse Reactions to Human Cells, Tissues and Organs
Mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals
Antiseptic Drugs for Human-Use
Asthma: Data Requirements for Safety and Effectiveness of Subsequent Entry Inhaled Corticosteroid Products Used for the Treatment of Asthma
B
Bioavailability and Bioequivalence
Comparative Pharmacokinetic Studies for Orally Inhaled Products: Guidance Document
Policy on Bioequivalence Standards for Highly Variable Drug Products – Notice
Clarification of bioanalytical method validation procedures – Notice
Conduct and Analysis of Comparative Bioavailability Studies
Comparative Bioavailability Standards: Formulations use for System Effects
Data Requirements for Safety and Effectiveness of Subsequent Market Entry Steroid Nasal Products for Use in the Treatment of Allergic Rhinitis
Preparation of Comparative Bioavailability Information for Drug Submissions in the CTD Format (draft)
ICH M9: Guideline on Biopharmaceutics Classification System-based Biowaivers
ICH M9: Q&A on Biopharmaceutics Classification System-based Biowaivers
C
Canadian Reference Product - Use of a Foreign-sourced Reference Product as a Canadian Reference Product
Cannabis - Health products containing cannabis or for use with cannabis
Certificate of Supplementary Protection Regulations (CSP)
Chemical Entity Products/Quality
Clinical Trials
Notice to Stakeholders – Clarification of Requirements under the Food and Drug Regulations when Conducting Clinical Research with Cannabis
Applications for drug clinical trials under the Interim Order: Guidance document
Clinical Trial Applications
Clinical Trials Manual
Clinical Trial Applications
Notice: Implementation of eCTD for Clinical Trial Regulatory Activities
Preparation of Clinical Trial Regulatory Activities in the "Non-eCTD Electronic-only" Format
Preparation of Clinical Trial Applications for use of Cell Therapy Products in Humans
Quality (Chemistry and Manufacturing) Guidance: Clinical Trial Applications for Pharmaceuticals
Template: Quality Overall Summary – Chemical Entities Clinical Trial Application – Phase I (QOS-CE (CTA – Phase I))
Template: Quality Overall Summary – Chemical Entities Clinical Trial Application – Phase II (QOS-CE (CTA – Phase II)) Template: Quality Overall Summary – Chemical Entities Clinical Trial Application – Phase II (QOS-CE (CTA – Phase II))
Template: Quality Overall Summary – Chemical Entities Clinical Trial Application – Phase III (QOS-CE (CTA – Phase III))
Update for Clinical Trial Sponsors: Requirements for Tuberculosis Screening of Healthy Volunteers in Phase I Clinical Trials involving Immunosuppressant Drugs or Drugs with Immunosuppressant Properties – Notice
Updated Notice: Regulatory Enrolment Process (REP) Non-Functional Pilot for Clinical Trials
Notice: Update to Clinical Trial Site Information Form
Standards for Clinical Trials in Type 2 Diabetes in Canada
Inclusion of Women in Clinical Trials
ICH M4: Common Technical Document
Common Electronic Submissions Gateway (CESG)
Common Technical Document (CTD)
Notice: Validation rules for regulatory transactions provided to Health Canada in the "non-eCTD electronic-only" format
Notice Applications for Investigational Testing Authorization (ITA), for Medical Devices, in the "Non-eCTD Electronics-Only" Format
Notice: Expansion of the medical device Regulatory Enrolment Process (REP) pilot and the scope for transactions sent via the Common Electronic Submissions Gateway (CESG)
Updated - Guidance Document: Preparation of Regulatory Activities in the "Non-eCTD Electronic-Only" Format
Notice: Preparation of Clinical Trial Regulatory Activities in the "Non-eCTD Electronic-Only" Format
Notice - Instructions for Submitting Drug Notification Forms (DNF) and Supporting Documents Provided in Electronic Format
Notice - Re: Preparation of Drug Master File (DMF) in "Non-eCTD Electronic-Only" Format
Guidance Document: Preparation of Drug Regulatory Activities in the Common Technical Document (CTD) Format
Notice - Preparation of Division 8 Regulatory Activities in the "Non-eCTD Electronic-Only" Format
Draft Guidance for Industry: Preparation of Comparative Bioavailability Information for Drug Submissions in the CTD Format
Guidance for Clinical Trial Sponsors: Clinical Trial Applications
Templates
Notice: Release of Draft Guidance Document for Consultation: Comparative Pharmacokinetic Studies for Orally Inhaled Products
Confidential Business Information – Disclosure under Paragraph 21.1(3)(c) of the Food and Drugs Act
Cost Recovery guidance documents for drug products and applications and submissions
Notice: Guidance Document Updates to Reflect New Fees and Policies for April 1, 2020
D
Data Protection under C.08.004.1 of the Food and Drug Regulations
Databases – Drug and Medical Devices
Diabetes: interim approach for evaluating cardiovascular risk for new antidiabetic therapies to treat Type 2 diabetes mellitus - Notice
Disinfectants
Disinfectant Drugs
Management of Disinfectant Drug Applications [in effect until March 31, 2020]
Management of Disinfectant Drug Applications [in effect April 1, 2020]
Safety and Efficacy Requirements for Contact Lens Disinfectants
Safety and Efficacy Requirements for Hard Surface Disinfectant Drugs
Safety and Efficacy Requirements for High-level Disinfectants and Sterilants for Use on Reusable Semi-critical and Critical Medical Devices
Drug Facts Table for Non-prescription Drugs
Drug Identification Number (DIN)
Preparation of DIN Submissions
Drug Identification Numbers for Schedule C Drugs (Radiopharmaceuticals and Kits) [in effect until March 31, 2020]
Drug Identification Numbers for Schedule C Drugs (Radiopharmaceuticals and Kits) [in effect April 1, 2020]
Regulatory Requirements for DINs
Drug Submission Status Requests
Drugs Currently Regulated as New Drugs
E
Electronic Common Technical Documents (eCTD)
F
Filing Submissions Electronically
Food and Drugs Act
Amendments to the Food and Drugs Act Guide to New Authorities
Consultation on the Amendments to the Food and Drugs Act: Guide to New Authorities – What We Heard
Notifying Health Canada of Foreign Actions
Foreign Reviews
G
Guidance Document on the Distribution of Drugs as Samples [2020-04-29]
Good Guidance Practices
Good Manufacturing Practices
Good manufacturing practices guide for drug products (GUI-0001) effective on 2018-10-01
Submission filing requirements – GMP/DEL
H
Human-Use Antiseptic Drugs
Haemodialysis Solutions
Helicobacter pylori
Hepatotoxicity - Pre-market Evaluation of Hepatotoxicity in Health Products
Hormone Replacement Therapy
Product Monographs of Non-Contraceptive Estrogen/Progestin-Containing Products
Guidelines for Preparation of a New Drug Submission for Products Used for Estrogen-Progestin Replacement Therapy in Menopause (HRT)
I
Inhalers
Guidance to Establish Equivalent or Relative Potency of Safety and Efficacy of a Second Entry Short-Acting Beta2-Agonist Metered Dose Inhaler
Guidance Document - Data Requirements for Safety and Effectiveness of Subsequent Market Entry Steroid Nasal Products for Use in the Treatment of Allergic Rhinitis
International Council for Harmonisation (ICH)
Applications for Investigational Testing Authorization (ITA), for Medical Devices, in the "Non-eCTD Electronics-Only" Format
L
Labelling
Drug Facts Table for Non-prescription Drugs
Labelling of Pharmaceutical Drugs for Human Use
Labelling Requirements for Non-prescription Drugs
Non-prescription Drugs: Labelling Standards – Drug Product
Look-alike Sound-alike (LA/SA) Health Product Names: Marketed Health Product Name Assessment
M
Master Files (MFs) – Procedures and Administrative Requirements
Management of Drug Submissions [in effect until March 31, 2020]
Management of Drug Submissions and Applications (formerly Management of Drug Submissions) [in effect April 1, 2020]
N
New Drugs
Listing of Drugs Currently Regulated as New Drugs (New Drugs List)
Non-Clinical Laboratory Study Data Supporting Drug Product Applications and Submissions: Adherence to Good Laboratory Practice
Questions and Answers
Non-prescription Drugs: Category IV Monographs
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
Notice of Compliance with Conditions
O
Official Methods
Conjugated Estrogens
Determination of the Disintegration Time of Tablets
Determination of Flame Projection
Determination of Net Contents
Thyroid
Opioids
Opioid Warning Sticker and Patient Information Handout, and Risk Management Plans
Tamper-resistance Formulations of Opioid Drug Products
Oral Contraceptives
P
Patented Medicines
Submission of Pharmacogenomic Information
Questions and Answers: Plain Language Labelling Regulations for Prescription Drugs [in effect April 1, 2020]
Pharmacometrics - Use in drug submissions and clinical trial applications: Policy statement
Plain Language Labelling Regulations for Non-prescription Drugs and Contact Lens Disinfectants – Questions and Answers [in effect until March 31, 2020]
Plain Language Labelling Regulations for Non-prescription Drugs – Questions and Answers [in effect April 1, 2020]
Post-Drug Identification Number (DIN) Changes
Post-Notice of Compliance Changes
Post-Notice of Compliance (NOC) Changes: Safety and Efficacy Document [in effect until March 31, 2020]
Post-Notice of Compliance (NOC) Changes: Safety and Efficacy Document [in effect April 1, 2020]
Guidance Document - Post-Notice of Compliance (NOC) Changes: Framework Document [in effect until March 31, 2020]
Post-Notice of Compliance (NOC) Changes: Framework Document [in effect April 1, 2020]
Post-Notice of Compliance Changes: Quality Document
Updated - Notice regarding the Post-Notice of Compliance (NOC) Changes: Notices of Change: Level III Form
Post-Notice of Compliance (NOC) Changes: Notices of Change (Level III) Form (PDF fillable/saveable (435 KB)) Please download form to your desktop before filling out.) [in effect until March 31, 2020]
Post-Notice of Compliance (NOC) Changes: Notices of Change (Level III) Form [in effect April 1, 2020]
Pre-market Evaluation of Hepatotoxicity in Health Products
Prescription status - Determining Prescription Status for Human and Veterinary Drugs
Priority Review
Product Monograph
Notice - Product Monograph Implementation Plans
Updated: Notice – Notification of Safety Labelling Changes to the Product Monographs of Pharmaceutical Drug Products
Product Vigilance
Q
Consultation on the Draft Guidance Document: Quality (Chemistry and Manufacturing): New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs); and the Certified Product Information – Chemical Entities (CPID-CE) Guidance Document and Template
QT/QTc Interval Prolongation
Quality
R
Reconsideration of Decisions Issued for Human Drug and Natural Health Product Submissions
Reconsideration of Final Decisions
Regulatory Enrolment Process
Regulatory Requirements for DINs
Review of Drug Brand Names
Frequently Asked Questions
S
Schedule A and Section 3 to the Food and Drugs Act
Source Establishment – Reporting Adverse Reactions to Human Cells, Tissues and Organs
Submission Filing Requirements – Good Manufacturing Practices (GMP)/Drug Establishment Licences (DEL)
T
Tablet Scoring of Subsequent-entry Pharmaceutical Products
Drug Submissions Relying on Third-Party Data (Literature and Market Experience)
U
Use of a Foreign-sourced Reference Product as a Canadian Reference Product
V
Product Vigilance
Veterinary Drugs Application and Submission Guidance Documents
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