FDA's Dr. Nasr: "I think we are changing the paradigm of how to assess quality of pharmaceuticals in the U.S. and in the world"

GMP News No. 470

GMP News
29 September 2004
 

FDA's Dr. Nasr: "I think we are changing the paradigm of how to assess quality of pharmaceuticals in the U.S. and in the world"

 
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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