Transcript Présentation PowerPoint - Indian Pharmaceutical Association

Monograph Development Process
for the European Pharmacopoeia:
How to participate in the work
programme of the European
Pharmacopoeia
Dr Claude Coune
Head of the Publication and IT
division
4 procedures
• Procedure 1: group of experts
• Procedure 2: adaptation of existing
national monograph
• Procedure 3: direct co-operation with
innovator, work co-ordinated by national
pharmacopoeia
• Procedure 4: direct co-operation with
innovator, work co-ordinated by EDQM
Stages in elaboration
• All four procedures :
– Addition to work programme by Commission:
public announcement (industry associations,
Pharmeuropa, web site)
– Interested parties can (and should!) express
an interest
– Elaboration, experimental checking of draft
– Publication in Pharmeuropa (3-month
comment period)
Stages in elaboration (2)
– Study of comments by group of
experts/working party
– Submission to Commission for adoption
– Publication within 6 months
– Implementation 1 year after adoption
• Overall timescale: minimum 2-3 years
Work status
• Key to information on status:
0 = on the work programme, no first draft
1 = first draft (new or revised monograph)
2 = published (or in press) in Pharmeuropa
3 = submitted to the Commission
4 = adopted, ready for publication
5 = published
Work programme
• Based on proposals from:
– National delegations
– Groups of experts
– EDQM
• Manufacturers can submit proposals via
one of the above
Work programme (2)
• Additions announced on web site
• Search engine at www.pheur.org for
complete work programme
• Communication via industry associations
New monographs: actives
• For active substances, aim is to have
monograph ≥ 2 years before patent expiry
• Addition to programme depends on:
– therapeutic importance
– extent of use
– number of countries in which product is
approved
– known quality problems
New monographs: excipients
• For excipients, important criteria
are:
– extent of use
– type of use (parenteral, oral, etc)
– number of preparations in which the
excipient is used
– known quality problems
How to participate
• Participation depends on the procedure
used
• For all procedures it is in your interest to
provide samples for testing
• Information on actives and excipients in
approved products is needed
Procedure 1
• Declare an interest in the monograph
being elaborated or revised
• Indicate willingness to provide
samples and to work with the group
• EDQM will organise contact with coordinator for the monograph
Direct participation
• Join a group of experts: contact your
national pharmacopoeia authority,
which makes proposals for experts
• Work as a co-opted expert for a
particular project that is of interest:
short-term commitment
Procedures 3 & 4
• EDQM contacts the innovator to
determine willingness to work on
monograph
• Close co-operation during elaboration
• Will be used systematically for singlesource products in future
Proposing a new monograph
• Contact your National Pharmacopoeia Authority
(in Europe) or EDQM (outside Europe)
• Initial data: countries where the product is
approved
• Data package:
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Current specification
Validation reports
Samples of substances and impurities
Full description of data package is available
Pharmacopoeia liaison
• EDQM wishes to have a pharmacopoeia
liaison contact for each major
manufacturer/user
• Channel information and requests from
manufacturer to EDQM
• Reception point for contact by EDQM
• Benefits for both sides
Revision
• Types of revision:
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Correction of a monograph/general chapter
Minor revision
Routine revision
Rapid revision
Corrections
• Correction of obvious errors (typos, etc.)
• Dealt with by Secretariat, notification to
Commission and national authorities
• No Pharmeuropa publication
• Effective from the official publication date
of the edition/supplement
• Occasionally used for rapid
implementation of a true revision
Minor revision
• Minor technical changes that do not need
to be published for consultation in
Pharmeuropa
• Adopted by Commission on the basis of a
briefing note
• Implemented with other revisions in next
edition/supplement
Routine revision
• Based on request for revision with
sufficient data
• Studied by group of experts
• Published in Pharmeuropa
• Adopted by Commission
• Implemented in next edition/supplement
Rapid revision
• Special procedure intended for use where
there is a serious public health concern
• Cumbersome (publication of resolution
and in official journal of each Member
State) and not very rapid
• Rarely used nowadays, “correction”
preferred (faster and simpler)
Revision programme
• Work programme is announced via web
site
• Declare an interest for relevant items
• Make sure you see Pharmeuropa for
revision proposals
• Provide samples, test draft proposal
Revision: why?
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New sources have new impurity profiles
Quality improves, monograph should keep in line
New quality issues arise
Analytical methods change: more convenient
methods, more powerful methods, more reliable
methods become available
• International harmonisation (PDG, ICH, VICH)
Revision: why? (2)
• FAQ: “Why did you revise the monograph
on…?”
• You can find out via:
– Briefing notes in Pharmeuropa
– Collected briefing notes posted on the web site
for each new edition/supplement
• There is no briefing note for corrections
How to request revision
• Commission decides on revision
• Based on proposals from:
– National delegations
– Groups of experts
– EDQM
• Manufacturers should submit via one of
these
How to request revision (2)
• Europe: via national pharmacopoeia
authority (address list in Pharmeuropa)
• Outside Europe: contact EDQM which will
refer the matter to a group of experts or to
the Commission
• Make clear what needs revising and if
possible make a concrete proposal
Data for revision
• Revision can only be undertaken if the
request is backed up by sufficient data
• Give batch data, sample chromatograms,
etc. to enable a decision on the need for
revision
Special revision programme
• Instituted in 2004 to replace TLC by
quantitative methods in about 140
monographs on APIs
• Phase 1: 2004-6, 40 monographs on APIs +
20 amino acids
• Manufacturers invited to submit data
• Information available on web site
Traditional Medicines
• 50 Chinese Traditional Medicines
(herbals),
– About 15 published, or about to be published
• Other traditions: Indian (?), South America
Knowledge database
• The whole programme of the European
Pharmacopoeia
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All published monographs
All monographs under elaboration
All monographs accepted for elaboration
Links to the catalogue of reference standards
Links to the Certification database
Additional information