At the meeting of the ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE from
July 20 to July 21 in Rockville, Maryland, the new initiatives (cGMP
Initiative, CMC risk-based approach, new GMP Inspection programme) that have
been set up by FDA were discussed intensively.
Among the speakers who gave an outstanding presentation was Dr Moheb
Nasr. Dr Nasr is Director of the Office of New Drug Chemistry, OPS, CDER,
FDA
With the words "I think we are changing the paradigm of how to
assess quality of pharmaceuticals in the U.S. and in the world" he
started his presentation at the Advisory Board Meeting. In the following he
made some important statements that can be summarized as follows:
- Regulatory submissions to the FDA are going to change completely!
- Instead of submitting a large set of raw data", the submission
will become a more scientific document ("information")
explaining how the manufacturing process
was developed, what is critical, what will probably be improved in the
process later on and how that is going to be managed. The control over the
process (PAT) will also be crucial in this.
- Dr Nasr's statement "If we at the FDA understand what you are
doing and you share with us your understanding, we have great confidence
in your ability to manage your own changes" summarizes the new
paradigm in only one sentence.
- This comes down to a drastic decrease in the filing-, reviewing and
(pre-) approving of Supplements. Industry will be allowed to manage many
of their changes without having to do Supplements, provided that the
manufacturer can show that he will handle change in the appropriate way.
Of course there will be inspections every now and then to check the
necessary documentation.
FDA is in a great hurry with this, also because their workload for
Supplements review is becoming unworkable rapidly now. Dr Nasr indicated
that the start of the implementation of the new concepts will not take years
but more like weeks, months.
The announcement was made on 29 September. Click here
to read the report.
Nevertheless, the FDA intends to, next to the new options, also maintain
the "traditional" submission approaches and procedures for
applicants who do not wish to or are not able to work according to the new
paradigm.
Dr Moheb Nasr is among the speakers at the European Conference: Active
Pharmaceutical Ingredients – GMP and Regulatory Affairs Conference from 20
to 22 October 2004 in Lisbon. This Conference is known as the most
important Conference on APIs in Europe. For 7 years now it has been
presented by APIC, a sector group of CEFIC. This conference will inform
about the latest development on FDA and European GMP Compliance
Issues for Active Pharmaceutical Ingredients. Dr Nasr will talk about the
current status of FDA 'Pharmaceutical Quality for the 21st
Century' – Initiative – Progress Update.
The information was provided by Dr. Chris Oldenhof, DSM.
Chris is Manager External Regulatory Affairs in the Safety, Health and
Compliance Department of the Business Group Anti-Infectives of DSM in Delft,
The Netherlands, Member of the Board of Management of CEFIC-APIC and member
of its Working Group on Regulatory Affairs
If you wish to read the complete presentation please click here.
If you wish to see the presentation slides shown by Dr Nasr please click
here.
Click here to read the
transcript of a second speech of Dr Nasr.
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