17/18 May 2021
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:
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