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USFDA Guidelines

 
Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products — Content and Format (PDF - 52KB)
 
Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products—Content and Format (PDF - 144KB)
 
Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products — Content and Format (PDF - 127KB)
 
Content and Format for Geriatric Labeling (PDF - 38KB)
 
Contents of a Complete Submission for the Evaluation of Proprietary Names (PDF - 306KB)
 
Content and Format of the Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products (PDF - 163KB)
 
Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims (PDF - 147KB)
 
Labeling for Combined Oral Contraceptives (PDF - 92KB)
 
Labeling for Human Prescription Drug and Biological Products — Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information (PDF - 65KB)
 
Labeling for Human Prescription Drug and Biological Products — Implementing the New Content and Format Requirements (PDF - 213KB)
 
Noncontraceptive Estrogen Drug Products for the Treatment of Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms--Recommended Prescribing Informtion for Health Care Providers and Patient Labeling (PDF - 458KB)
 
Public Availability of Labeling Changes in "Changes Being Effected" Supplements (PDF - 26KB)
 
Referencing Discontinued Labeling for Listed Drugs in Abbreviated New Drug Applications (PDF - 32KB)
 
Topical Acne Drug Products for Over-the-Counter Human Use--Revision of Labeling and Classification of Benzoyl Peroxide as Safe and Effective (PDF - 123KB)
 
Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices (final) (PDF - 208KB)
 
Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products — Content and Format (PDF - 102KB)
 
Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products
 
Container Closure Systems for Packaging Human Drugs and Biologics (PDF - 164KB)
 
Container Closure Systems for Packaging Human Drugs and Biologics -- Questions and Answers (PDF - 15KB)
 
Expiration Dating of Unit-Dose Repackaged Drugs: Compliance Policy Guide (PDF - 19KB)
 
Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products (PDF - 64KB)
 
Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products (PDF - 64KB)
 
Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation (PDF - 45KB)
 
Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation (PDF - 45KB)
 
Size of Beads in Drug Products Labeled for Sprinkle (PDF - 43KB)
 
Tablet Scoring:Nomenclature, Labeling, and Data for Evaluation (PDF - 99KB)
 
Letter to regulated industry notifying interested parties about important detailed information regarding labeling, scale-up, packaging, minor/major amendment criteria and bioequivalence requirements (PDF - 908KB)
 
Revising ANDA Labeling Following Revision of the RLD Labeling (PDF - 19KB)
 
Guidance for Industry: Bar Code Label Requirements (PDF - 72KB)
 
Expiration Dating of Unit-Dose Repackaged Drugs: Compliance Policy Guide (PDF - 19KB)
 
Safety Labeling Changes -- Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act (PDF - 129KB)
 
Indexing Structured Product Labeling (PDF - 59KB)
 
Providing Regulatory Submissions in Electronic Format — Content of Labeling (PDF - 28KB)
 
Providing Regulatory Submissions in Electronic Format - Prescription Drug Advertising and Promotional Labeling (PDF - 28KB)
 
SPL Standard for Content of Labeling Technical Qs & As (PDF - 58KB)
 
Implementation of Section 126 of the Food and Drug Administration Modernization Act of 1997 - Elimination of Certain Labeling Requirements. (PDF - 979KB)
 
Labeling OTC Human Drug Products; Small Entity Compliance Guide (PDF - 270KB)
 
Topical Acne Drug Products for Over-the-Counter Human Use--Revision of Labeling and Classification of Benzoyl Peroxide as Safe and Effective (PDF - 123KB)
 
Aerosol Steroid Product Safety Information in Prescription Drug Advertising and Promotional Labeling (PDF - 84KB)
 
Example of Fictional Highlights of Prescribing Information (Based on Proposed Physician Labeling Rule) Translated in Consumer-Friendly Language and Formatted for Use in Consumer-Directed (PDF - 95KB)
 
Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling (PDF - 153KB)
 
Aerosol Steroid Product Safety Information in Prescription Drug Advertising and Promotional Labeling (PDF - 84KB)
 
Example of Fictional Highlights of Prescribing Information (Based on Proposed Physician Labeling Rule) Translated in Consumer-Friendly Language and Formatted for Use in Consumer-Directed (PDF - 95KB)
 
Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling (PDF - 153KB)
 

EU Guidelines

 
Plastic Primary Packaging Materials
 
 

Health Canada Guidelines

 
Draft Guidance Document Labelling of Pharmaceutical Drugs for Human Use  Portable Document Format(PDF Version - 1,122 K)
 
Standard Operating Procedures (SOP) - Using the Pharmaceutical Labelling Assessment Templates (PLATs) to Prepare Labelling Reports on Applications / Submissions for Marketing Authorization                                                                                                                              Portable Document Format (PDF Version - 203 K)
 

MHRA Guidelines

 
Best Practice Guidance on the labelling and packaging of medicinesPDF file (opens in new window) (226Kb)
 
Signposting from the patient information leaflet to additional sources of information and other servicesPDF file (opens in new window) (69Kb)
 
Labelling and packaging of medicines: Quick Response (QR) codesPDF file (opens in new window) (37Kb)
 
A guideline on the readability of the label and package leaflet of medicinal products for human use (external link)
 

WHO Guidelines

 
Guidelines on packaging for pharmaceutical products