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

29 September 2004

FDA'sDr. Nasr: "Ithink we are changing the paradigm of how to assess quality ofpharmaceuticals in the U.S. and in the world"

At the meeting of the ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE fromJuly 20 to July 21 in Rockville, Maryland, the new initiatives (cGMPInitiative, CMC risk-based approach, new GMP Inspection programme) that havebeen set up by FDA were discussed intensively.

Among the speakers who gave an outstanding presentation was Dr MohebNasr. 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 toassess quality of pharmaceuticals in the U.S. and in the world" hestarted his presentation at the Advisory Board Meeting. In the following hemade 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 submissionwill become a more scientific document ("information")explaining how the manufacturing processwas developed, what is critical, what will probably be improved in theprocess later on and how that is going to be managed. The control over theprocess (PAT) will also be crucial in this.
  • Dr Nasr's statement "If we at the FDA understand what you aredoing and you share with us your understanding, we have great confidencein your ability to manage your own changes" summarizes the newparadigm 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 manyof their changes without having to do Supplements, provided that themanufacturer can show that he will handle change in the appropriate way.Of course there will be inspections every now and then to check thenecessary documentation.

FDA is in a great hurry with this, also because their workload forSupplements review is becoming unworkable rapidly now. Dr Nasr indicatedthat the start of the implementation of the new concepts will not take yearsbut more like weeks, months.

The announcement was made on 29 September. Click hereto read the report.

Nevertheless, the FDA intends to, next to the new options, also maintainthe "traditional" submission approaches and procedures forapplicants who do not wish to or are not able to work according to the newparadigm.

Dr Moheb Nasr is among the speakers at the European Conference: ActivePharmaceutical Ingredients – GMP and Regulatory Affairs Conference from 20to 22 October 2004 in Lisbon. This Conference is known as the mostimportant Conference on APIs in Europe. For 7 years now it has beenpresented by APIC, a sector group of CEFIC. This conference will informabout the latest development on FDA and European GMP ComplianceIssues for Active Pharmaceutical Ingredients. Dr Nasr will talk about thecurrent status of FDA 'Pharmaceutical Quality for the 21stCentury' – Initiative – Progress Update.

The information was provided by Dr. Chris Oldenhof, DSM.

Chris is Manager External Regulatory Affairs in the Safety, Health andCompliance Department of the Business Group Anti-Infectives of DSM in Delft,The Netherlands, Member of the Board of Management of CEFIC-APIC and memberof its Working Group on Regulatory Affairs



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