Genericos, presentacin SJCR, setiembre 2000

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CERTIFICATE OF PHARMACEUTICAL PRODUCT
-An Authority View
PROF. LETICIA-BARBARA B. GUTIERREZ, MS
Director Bureau of Food and Drugs-Department of
Health
Philippines
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Outline of Presentation

• The Scheme
• Assessment / Evaluation
• Advantages

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WHO Certification Scheme
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The WHO Certification Scheme

• Administrative tool for interchange of
  information among National Regulatory
  Authorities
  
• Based on
• voluntary, non-binding agreement
• self-assessment of regulatory capacity
• Intended to facilitate trade of
  pharmaceuticals of good quality, safety,
  efficacy and to hinder international
  circulation of substandard products

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The WHO Certification SchemeBRIEF HISTORY

• 1963 World Health Assembly (WHA) resolution
  ways and means of ensuring that drugs exported
  from a producing country comply with drug control
  requirements which apply in that country for
  domestic use
• 1969 WHA adopted Good Practices in the
  Manufacture and Quality Control of Drugs
  
• list of manufacturers complying with GMP to
  be issued by governments
  
• batch certificates to be issued by health
  authorities of exporting countries

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The WHO Certification Scheme
1975 revision Includes the regulatory status of
product in exporting country and the GMP
compliance of manufacturing site
1988 revision Applicable to finished dosage fo
rms of pharmaceutical products intended for
administration to human beings or to
food-producing animals 1992 current version, op
erational since 1997
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The WHO Certification Scheme
Who can participate? Any Member State by notif
ying the World Health Organization, in writing,
of - its willingness to participate in the Sc
heme - any significant reservations it inten
ds to observe relating to this participation
and - the name and address of its national drug
regulatory authority or other competent
authority.
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The WHO Certification Scheme
5 prerequisites for participation
1 - effective national licensing system for phar
maceutical products, manufacturers and
distributors 2 - GMP requirements, consonant w
ith WHOs, compulsory for all manufacturers
3 - effective controls to monitor the quality of
pharmaceutical products registered or
manufactured within its country
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The WHO Certification Scheme
5 prerequisites for participation (cont.)
4 - a national pharmaceuticals inspectorate empo
wered to conduct inspections and with
competence, experience and resources to assess
GMP compliance 5 - administrative capacity to
issue certificates, to institute inquiries in
the case of complaint, and to notify both WHO
and the authority in any Member State that a
specific product has been subsequently
associated with a potentially serious quality
defect or other hazard.
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The WHO Certification Scheme
What products are covered? - pharmaceutical pro
ducts for both human and veterinary use that are
subject to marketing authorisation in the
certifying country - active pharmaceutical ingr
edients (through separate guidelines and
certificates)
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The WHO Certification Scheme
Three Types of Certificates a. Certificate of
a Pharmaceutical Product (Product
Certificate, CPP, CoPP)
-used in connection with drug registration,
variations and renewals b. Batch Certificat
e of a Pharmaceutical Product -used in connecti
on with individual shipments c. Statement of Li
censing Status of Pharmaceutical Products
-used in connection with international tenders
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The WHO Certification Scheme
Who issues the Certificates? Certificate of a P
harmaceutical Product (Product Certificate, CPP,
CoPP) -Drug regulatory authorities of exporting
countries Batch Certificate of a Pharmaceutical
Product -National authorities of exporting count
ries for biologicals, otherwise manufacturer
Statement of Licensing Status of Pharmaceutical
Products -National authorities of exporting count
ries
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The WHO Certification Scheme
What do Certificates say? - a specific product
is authorized for marketing in certifying
country or , if not so, the reason why that
authorization has not been given
- the plant in which it is produced is subject t
o inspections at suitable intervals and it
conforms to GMP as recommended by WHO and
- all submitted product information, including l
abelling, is currently authorised in the
certifying country.
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The WHO Certification Scheme

• What do Certificates imply?
• The certifying authority has satisfied itself,
  before attesting compliance with GMP, that the
  applicant
  
• applies identical GMP standards to the production
  of all batches manufactured within the facility,
  including those exclusively for export
  
• consents, in the event of identification of a
  quality defect, to inspection reports being
  released, in confidence, to the authority of the
  importing country

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WHO Certification Scheme
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Assessment / Evaluation
Applicant in importing country, importer
AUTHORITY OF IMPORTING COUNTRY
Manufacturer, licence holder, supplier
AUTHORITY OF EXPORTING COUNTRY
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Assessment/Evaluation
Decision tree for use of CPP in drug registration
process
STEP 1
Yes
CPP submitted?
Go to step 2
No
Ask applicant to submit CPP or Rejec
t application for
inadequate documentation
Is manufacturing country USA, or member of ASEAN,
PIC/S or EU?
Yes
No
Conduct full assessment or Reject ap
plication for
inadequate documentation
GMP inspection reports should be relevant to
the dosage form(s) object of the application
and sufficient detailed to satisfy
evaluator of compliance with ASEAN GMP
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Decision tree for use of CPP in drug registration
process
STEP 2
Ask applicant to submit more recent CPP
or Reject application for inadequate documen
tation
Yes
CPP older than 6 months?
No
CPP complies with WHO format and full list of
ingredients and SPC attached?
Yes
Go to Step 3
No
Is evaluator satisfied with information provided
instead of list and SPC (i.e. other official docu
mentation providing same information)?
Yes
No
Ask applicant to submit missing information
or
Reject application for inadequate documentation
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Decision tree for use of CPP in drug registration
process
STEP 3
Yes
Is CPP from a listed country?
Go to step 4
No
Obtain recent, full GMP inspection report
or Organise site inspection
or Reject for insufficient evidence of
GMP
Can evaluator provide good assurance of implement
ation
of GMP in manufacturing site?
No
Yes
Is same active ingredient (or
combination), form and strength
already on the market?
Recommend full assessment of safety and efficacy
or Reject application for inadequ
ate documentation
No
Yes
Go to step 4
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Decision tree for use of CPP in drug registration
process
STEP 4
Recommend full assessment of quality, safety and
efficacy or Reject application for
inadequate documentation
Does product have MA in certifying country?
No
Yes
No
Is product the same as in certifying country?
Yes
No
Approve and recommend - review of analytical met
hods - assessment of bioequivalence, if required
- review and adaptation of SPC - review of
stability to match local requirements
Are differences acceptable?
Yes
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Assessment / Evaluation
What is the country of origin ?
Country where the final dosage form has been
manufactured, batch release takes place, or from
where products are shipped to the importing
country. Sometimes it is not possible to ident
ify one country of origin but rather several
countries of origin. Crucial is to have suffi
cient information to understand reasons for
having several countries of origin and to be
satisfied about product quality, safety and
efficacy. This may entail obtaining more than
one CPP.
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What to do when in doubt? (Regulatory Authority)
Check web site of certifying authority (if any,
if possible, if it contains information)
Contact certifying authority Contact other na
tional authorities Conduct assessment ignoring
certificate
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WHO Certification Scheme
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Importance of the CPP

• Advantages
• Standardised format defining what information
  should be provided
  
• Mechanism to improve interchange of
  information and to offer follow-up on complaints

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Thank you!