THE CERTIFICATE OF PHARMACEUTICAL PRODUCT Industry Perspective

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THE CERTIFICATE OF PHARMACEUTICAL PRODUCT-
Industry Perspective -

• Dr. Michael Gebauer
• Head Regulatory Affairs Asia-Pacifc
• Bayer Schering Pharma
• Singapore

2008-03-11 / 1630-1645
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Certificate of Pharmaceutical Product

• WHO certification scheme
• Use of CPP by national Authorities
• Alternative sources of information

.) Guidelines on the implementation of the WHO
certification scheme on the quality of
pharmaceutical products moving in international
commerce.
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Certificate of Pharmaceutical Product
Use of CPP by national Authorities To provide
evidence about positive assessment of SEQ and
GMP from a reference regulatory Authority. Is
used by regulatory Authorities in developing
markets to assist in cases of limited internal
resources which may have not allowed to evaluate
the application in a given timeframe. Data given
on a particular CPP had been used for
administrative purpose of national product
license.
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Certificate of Pharmaceutical Product

• Use of CPP by national Authorities cont.
• CPP is intended for use by the competent
  authority within an importing country in two
  situations
• when the product in question is under
  consideration for a product licence that will
  authorize its importation and sale
• when administrative action is required to renew,
  extend, vary or review such a licence.

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Delay of access of new drug by use of CPP
Actually the CPP was designed to accelerate
access to new medicine.

• But request of CPP can cause delay in access to
  new medicine !
• Non CPP dependent submission and approval no
  delay by CPP
• CPP is a precondition before final
  approval. delay, no parallel approval
• (file CPP during the review process) possible,
  
• CPP is a must for submission delay, wait for
  approval in ref. country and min. 1 mo for
  processing CPP before filing
• CPP legalized by the embassy for
  submission further delay, embassy signature
  can takes 2 m
• More than 1 country CPP as precondition for
  submission.
• further delay by time to second
  approval and CPP

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Certificate of Pharmaceutical Product

• Current situation in Asia/Pacific in respect to
  need of CPP for application of license for new
  drug
• submission with 2 CPPs , legalization with
  apostille is accepted
• submission with CPP to be legalized by embassy
• submission with certified approval letter
• submission with CPP out of a list of countries
• submission with CPP, exception for special
  category
• submission for first step without CPP possible,
  but before approval CPP
• from country of manufacture required
• non CPP submission with full evaluation possible
  or
• reference country (CPP) submission for quicker
  process.
• submission with CPP depending on classification
  of the drug
• submission with CPP from any country is required
• submission with CPP from country of origin only
• non CPP submission is the usual case.

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Certificate of Pharmaceutical Product

• Does the CPP has to come from a particular
  country (CoM) ?
• The positive assessment of SEQ not necessarily
  has to come from the country of manufacture.
  Under the condition that it is the same product,
  other Authority CPPs should be as well accepted.
• If the evidence of the GMP status is the purpose
  of the CPP, separate GMP certificate can be made
  available.

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Certificate of Pharmaceutical Product
Actually the CPP was designed to accelerate
access to new medicine. If a national regulatory
Authority requests a CPP the delay in providing
that CPP, meaning waiting for reference country
approval, should be counterbalanced by an
accelerated approval process in a CPP demanding
regulatory process. This would give back the
CPP scheme its original intention under the WHO
regulatory frame.
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Certificate of Pharmaceutical Product
Can a CPP be replaced ? Harmonizaton and
communication had improved over the last 20
years. Evidence of reference country approval
can be obtained reliable by use of electronic
media or communication in between
Authorities. Evidence on approval in reference
country should result in accelerated review and
approval process. Reference country approval can
accelerate access to new medicine for patients in
a modern way.
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Certificate of Pharmaceutical Product
Reference country approval scheme can be smart
solution to avoid undue delay in access of new
medicine to patiens, if the national regulatory
process rewards the evidence of reference
country approval with an accelerated proccesing
of the application of new drug. The independent
review with interactive communication in between
Authority and applicant as well in between
Authority and Authority is a direction we see
already and expect to see more in Asia/ Pacific.
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Certificate of Pharmaceutical Product
terima kasih thank you for your attention
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Back up
Delay caused by CPP and Leglaization (average)
Result in overall delay for submission