FINAL DRUG REGISTRATION For Barbados - Pps
FINAL DRUG REGISTRATION For Barbados - Pps
FINAL DRUG REGISTRATION For Barbados - Pps
Regulatory Function
of
DRUG REGISTRATION
Celeste Sánchez González, PhD.
Adviser. CECMED/Cuba
[email protected]/[email protected]
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Content of the Presentation
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An approach of Regulatory Functions of Medicines
National Regulatory Authorities (1)
Administrative Elements
Technical
elements Regulation level
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Another approach of Regulatory Functions of
Medicines National Regulatory Authorities (2)
1 Regulatory System
2 Licenses: For medicines -vaccines- (Registration)
Licenses: For Companies (manufacturing, importing,
exporting, distributing)
3 Post-marketing surveillance
4 Lot Release
5 Access to Laboratory (for quality controls)
6 Regulatory Inspections: GMP and distribution channels
7 Regulatory overview to clinical trials
(2) Milstein J. Belgharbi L. Regulatory pathways for vaccines for developing countries. WHO.
Bulletin of the World Health Organization, February 2004
II Workshop on Medicines Regulation in the Caribbean Region
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Drug Registration
An important task for a Drug National
Regulatory Authority (NRA) is to institute a
system which subjects all pharmaceutical
products to:
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Drug Registration
(4) How to implement Computer-Assisted Drug Registration. Annex 2. Regulatory Support Series, No.
2. Geneva, WHO/MSH, 1998.
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Drug Registration Results
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Drug Registration
•Registration
•Variations
Manufacturer •Renewals
Pharmaceutical Product
Quality
GMP Safety
Requirements Information Efficacy
Laboratory
Inspections and Rational Use/Promotion
Post Marketing Controls
Establishment Licenses and Advertising
and Surveillance
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Drug Registration Requirements in
Terms of Regulation for a NRA
• Legal Bases
• Guidelines
• Assessment procedures
• Human resources and others
• Records
• Availability of the information
(5) WHO DATA COLLECTION TOOL (To be used jointly with the Guidance for the
assessment of Drug Regulatory Systems). WHO, 2009
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Drug Registration Assessment and
Requirement Characteristics
BASIS OF REGISTRATION
RELY ON REPORTS OF
ASSESSMENT FRON
ANOTHER NRA
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REGISTRATION. RELY ON EXPORTING CONTRY´S NRA
Yes No
Yes No No
• Check whether analytical methods for finished product can be applied at NQC laboratory
• Check if stability studies were conducted including the national climatic zone requirements
• Review, (adapt if necessary) labelling and product information/ Assess interchangeability, if required
(5) WHO. Marketing Authorization. A manual for Drug Regulatory Authorities…..
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Drug Registration. Phases for the Assessment
Reception
(Checking the formal validity of the Application)
Assessment
Quality: (Product design/Manufacturing GMP profile)
Product Information: (Labels, Information for patients information for
health professionals)
Interchangeability/Safety and efficacy
Follow-up
Post-marketing activities
(Update stability data, variations of the product/specifications/manufacturing
process, update product information, marketing status, control of promotional
activities, pharmacoepidemiological studies, monitor adverse drug reactions)
(4) How to implement Computer-Assisted Drug Registration. Regulatory Support Series, No. 2. Geneva, WHO/MSH, 1998:50.
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Drug Registration Requirements
OWN ASSESSMENT. DIFFERENT PARTS OF THE INFORMATION
PRODUCT INFORMATION
QUALITY
INTERCHANGEABILITY
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PANDRH* DRUG REGISTRATION REQUIREMENTS
LEGAL AND ADMINISTRATIVE INFORMATION
• Trademark
• INN (7) or generic name
• Concentration or strength
• Pharmaceutical form
• Technical Director
• Country Legal Representative
• International License Holder.
• Manufacturer of Active Pharmaceutical Ingredient (s) (API): Name,
address, telephone, fax, mail
• Manufacturer (s) of the Finished Pharmaceutical Product (FPP):
Name, address, telephone, fax, mail
• Another manufacturers of the FPP: Name, address, telephone, fax,
mail of other manufacturers in case they participate in any stage of the
FPP. For freeze dried products also should be declared the manufacturer
of diluents
• Commercial presentation (Primary container)
• Route of Administration
(7) WHO Guidelines on the Use of International Nonproprietary Names (INNs) for Pharmaceutical
II Workshop on Medicines Regulation in the Caribbean Region
Substances, 1997, WHO MD. Available at:
http://www.who.int/druginformation/general/innlists-shtml.
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PANDRH REGISTRATION REQUIREMENTS
LEGAL AND ADMINISTRATIVE INFORMATION
• Shelf life and storage conditions
• Dispensing category
• Quali-quantitative formulation per dosage unite and %.
• Legal documentation for:
Technical Director
Representative
Certificate of a Pharmaceutical Product (CPP)
Certificate of GMP for manufacturers taking part in
any step of the FPP (including activities authorized)
Trade mark certificate
• Information of the product:.
Labelling (inner container and secondary package)
Insert
Information for health professionals
• Samples or Mock ups of the final package for marketing
(including accessories)
• Samples of the finished products
• Quality Analysis Certificate (corresponding to the bath of the
samples)
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PANDRH REGISTRATION REQUIREMENTS
BASIC INFORMATION FOR INNER
CONTAINERS
Trademark
INN or generic name
Pharmaceutical form
Concentration or strength
Content/Volume
Number of dosages per vial (for multidose presentations)
Route of Administration
Storage conditions (if container size is big enough)
Warnings
Batch number
Expiry date
Manufacturer
Registration Number (according to the country legislation/container size)
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PANDRH REGISTRATION REQUIREMENTS
BASIC INFORMATION FOR SECONDARY
PACKAGE
Trademark Distribution level (according
INN or generic name to country legislation)
Pharmaceutical form Special signals (according to
Concentration or strength country legislation)
Content/Volume Batch number
Number of dosages per vial Expiry date
(for multidose Name and address of the
presentations) manufacturing of the FPP
Composition Name and address of the
Declaration of excipients packer of the FPP (if
(according to country different)
legislation) Name of the Technical
Storage conditions Responsible (according to
Route of Administration country legislation)
Instructions for preparation Registration Number
Instructions (according
for use on Medicines Regulation in the Caribbean
II Workshop to country
Region
Warnings (according to the legislation)
package size) Barbados, September
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PANDRH REGISTRATION REQUIREMENTS
BASIC INFORMATION FOR INSERTS
Trademark Precautions
INN or generic name Warnings
Pharmaceutical form Contraindications
Concentration or strength Over dosage
Content/Volume Use in pregnancy and
Number of dosages per vial lactation
(for multidose Shelf life and storage
presentations) conditions
Composition Name and address of the
Declaration of excipients manufacturing of the FPP
Route of Administration Name and address of the
Indications packer of the FPP (if
Instructions for use different)
Dosage/ Posology
Maximal dosage in 24 hours
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PANDRH REGISTRATION REQUIREMENTS
BASIC INFORMATION FOR QUALITY
Active Pharmaceutical Ingredient (s):
Chemical name (WHO/Relevant Pharmacopoeia)
Manufacturer (s): (According to country legislation). Note: For fixed drug
combinations (FDC), this information applies for each API
Characteristics:
Complete description (odor, taste, flavor, etc.)
Physical
Chemical
Specifications of API
• Analytical Method:
Validation of the Analytical method (According to country
legislation).
• Validity period
• For New Molecular Entities:
Structural and molecular formula/ Molecular weight/ Synthesis/
Source
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PANDRH REGISTRATION REQUIREMENTS
BASIC INFORMATION FOR QUALITY
Finished Pharmaceutical Product:
• Description and composition:
• Full description of the FPP, detailing API (s), preservatives,
stabilizers and other excipients and their function,
• For freeze dried products should be included description and
close-container system for dissolvent.
• Pharmaceutical development: Studies for establishing the
pharmaceutical form, formulation, manufacturing process and
close-container system
• Manufacturing of the FPP:
Batch formula (List of all components according country
legislation)
Manufacturing process (Flow with critical steps, in
process controls, intermediate products and FPP)
• Physical and chemical characteristics for excipients (according
country legislation)
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PANDRH REGISTRATION REQUIREMENTS
BASIC INFORMATION FOR QUALITY
FPP Control
• Specifications
• Analytical Methods
• Validation of analytical methods of the FPP including
experimental data
• Standards and reference materials information
• Description of the close-container system (including
specifications of component materials)
• Stability studies (according to the country legislation and
climatic zones):
Protocols and results of stability studies justifying validity
period: (According to country legislation including:
study protocol, specifications, analytical methods,
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PANDRH REGISTRATION REQUIREMENTS
BASIC INFORMATION FOR QUALITY
FPP Control
description of close-container system,
storage conditions (temperature and humidity)
results of 3 batches minimal manufactured with 3 different batches of API,
conclusions and proposed validity period).
For freeze dried products should be demonstrated compatibility between
lyophilized and diluents
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PANDRH REGISTRATION REQUIREMENTS
BASIC INFORMATION FOR
INTERCHANGEABILITY
Biopharmaceutical Information
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PANDRH REGISTRATION REQUIREMENTS
BASIC INFORMATION FOR
NON CLINICAL STUDIES
• Pharmacodinamics studies
• Pharmacokinetics studies
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PANDRH REGISTRATION REQUIREMENTS
BASIC INFORMATION FOR
NON CLINICAL STUDIES
Applicable for New Molecular Entities
• Pharmacodinamic studies
• Pharmacokinetics studies
• Toxicology studies
General Toxicology
Special toxicology
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PANDRH REGISTRATION REQUIREMENTS
BASIC INFORMATION FOR
CLINICAL STUDIES
Applicable for New Molecular Entities
Summary of Clinical Studies
• Phase II studies
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THANK
II Workshop on YOU
Medicines VERY inMUCH
Regulation the Caribbean Region
MUCHAS
Barbados, GRACIAS
September
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