GUIDELINE FOR APPLICANTS AND MODEL APPLICATION FORM IN ETHIOPIA by aya20861

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									   GUIDELINE FOR APPLICANTS
              AND
   MODEL APPLICATION FORM
          IN ETHIOPIA




Prepared and presented by:
               Bekele Tefera
               EDM/NPO
       WHO country office-Ethiopia

Work shop on Good Manufacturing Practice
  (GMP) and Good Distribution Practice
  (GDP) for domestic manufacturers, drug
  distributors and drug inspectors
Nazareth, Ethiopia, 3-7 June 2002


                                       1
                  General

• DRAs prepare registration
  guideline
• Applicants are expected to comply
  with these guidelines.

Principal criteria of registration

•   Safety
•   Efficacy
•   Quality
•   Labeling requirements


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Tefra, EDM/NPO,
 Ethiopia
        Strategies of drug
            evaluation

• Documentary evaluation
• Laboratory analysis

Important terms

Efficacy – the ability to produce the
   purported effect as determined by
   scientific methods

Safety- the absence of an unaccepted
  harmful effects (i.e. negative risk/benefit
  ratio) of a drug to the health of the
  consumer when used according to the
  instructions on/or enclosed in the
  package.
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Tefra, EDM/NPO,
 Ethiopia
                Quality


The nature of a drug determined by
  identity, content, purity, and other
  chemical, physical and biological
  properties or by the manufacturing
  process.

New product- is a product containing :
• New chemical entity
• New salts and esters of an active
  ingredient
• New fixed combinations
• New indication
• new dosage form

Bekele Tefra,                            4
EDM/NPO,
Ethiopia
     Types of registration
        applications
1.    New Drug Application (NDA)

2.    Abbreviated New Drug Application
      (ANDA)

3.    Various other forms of application
      including:

•     Re registration
•     Change of origin
•     Change of pack size
•     Change of container closure
•     Change in formulation
•     Change in the production process
•     Change in quality specifications/quality
      control method

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Tefra, EDM/NPO,
 Ethiopia
    Requirements for ANDA

An ANDA is an application for
 the registration of a product
 containing an active ingredient
 which has been used
 extensively and for which
 sufficient evidence exists to
 demonstrate its safety and
 efficacy (i.e. generic product)
Such kind of application should
 be accomplished by the
 following administrative data
 and technical data:

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Tefra, EDM/NPO,
 Ethiopia
            Administrative data


• Application form
• Agency agreement
• WHO-type Certificate of
  pharmaceutical products ( for
  manufacturers abroad)
• Manufacturing license (for
  domestic manufacturers)
• Registration fee




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Tefra, EDM/NPO,
 Ethiopia
                Technical data

1. Quality

a.     Data on active ingredient
•      Non propriety name
•      Molecular formula
•      Structure
•      Synthesis
•      Physico chemical properties
•      Stability
•      Key raw materials
•      Key intermediates
•      Degradation profile
•      Quality specifications
•      Test methods

Bekele Tefra,                        8
EDM/NPO,
Ethiopia
         Method of manufacture of the
          finished product showing:


•     Qualitative & quantitative
      composition
•     Batch manufacturing formula
•     In-process quality control
•     Data on container-closure
•     Process validation
      information




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Tefra, EDM/NPO,
 Ethiopia
            c.    Analytical Report


•     Quality specifications
•     Analytical methods
•     Validation information

d. Stability study report

•     Results of a study on at least two batches
•     Batch NO. Manufactory date & expiry date
•     Nature of container closure
•     Storage condition (T0, R?H, Light, etc)
•     Results of test parameters at each test
      interval (for real time studies at
      0,3,6,12,24,36, etc months)
•     For accelerated stability studies a maximum
      of 6 months data
•     Data on degradation products
•     Proposed storage conditions and shelf life



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Tefra, EDM/NPO,
 Ethiopia
         e.       Laboratory analysis


Samples of actual products are
  required for laboratory
  analysis

2. Efficacy
a. Assumed to have been
   established
b. In vivo bioequivalence data




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Tefra, EDM/NPO,
 Ethiopia
       3.       Labeling information




Drug product = chemical + Information



• Package insert

• Label of the immediate container

• Outer wrapper or carton




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EDM/NPO,
Ethiopia
                  Package insert


Must show:

•   Name of the product (INN)
•   Description
•   Composition
•   Clinical pharmacology
•   Warnings, precautions, contraindications
•   Adverse effects
•   Dosage administration
•   Over dosage
•   Potential of drug abuse and dependence
•   How supplied
•   Name and address of the manufacturer
•   Date of the last review

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Tefra, EDM/NPO,
 Ethiopia
     Label of the immediate
           container
Should show:
• Name of the product (INN)
• Pharmaceutical form
• Composition
• Quantity in container
• Technical direction
• Contraindications, warnings, preca
  utions
• Storage conditions
• Manufactory date and expiry date
• Batch number
• Name and address of the
  manufacturer
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Tefra, EDM/NPO,
 Ethiopia
    Outer wrapper or carton

Must bear all the information
 enumerated under package
 inserts




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Tefra, EDM/NPO,
 Ethiopia
           New drug Application

An NDA is an application for the
   registration of a new product as
   defined above and such kind of
   application must be accompanied
   by the following administrative
   data.
1. Quality

All the quality data enumerated under
     abbreviated drug application

2. Efficacy
a. In vitro models

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EDM/NPO,
Ethiopia
    b.        Animal pharmacology



•     Pharmaco dynamic
•     Pharmacokibnetic

c. Clinical study results
• Clinical pharmacology
   (pharmacodynamic/kinetic)
• Bioavailability study
• Clinical trial results
     (Phase I,II,II)


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Tefra, EDM/NPO,
 Ethiopia
                  Safety

Toxicological studies including:
• Acute toxicity
• Sub acute toxicity and chronic
   toxicity
• Reproductive and teratology
• Fertility
   Embryo toxicity/teratology
   Perinatal and post natal studies
   Carcinogenicity
     4. Labeling information
     As indicated for ANDA

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Tefra, EDM/NPO,
 Ethiopia
                  REFERENCES

1.    CIOM (1983): Safety requirements for the first
      use of new drugs and diagnostic agents in man.
      Geneva: CIOM. A review of safety issues in
      early clinical trials of drugs
2.    Ministry of Health of Ethiopia (1996):
      Consolidated guidelines on the requirements
      for the registration of products and
      manufacturing companies;
3.    WHO (1985): Draft guideline on the
      requirements for registration of drugs. WHO-
      Eastern Mediterranean region. WHO-EDM
      (PHARM?105)
4.    WHO (1975): Guidelines for evaluation of drugs
      for use in man. Geneva: WHO. Scientific group
      WHO technical report series No. 563




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Tefra, EDM/NPO,
 Ethiopia

								
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