Regulatory review process

Perhaps most significant is the regulatory uncertainty associated with a new approach to manufacturing control. As described in Chapter 2, validation requirements are different for on-line and in-line tools than for laboratory assays, and there is concern that any uncertainties during the regulatory review process will lead to delayed product launches. 

It is clear that the FDA considers that the CMC section has the potential to significantly decrease NDA review and approval times. In addition to the issuance of guidance documents and CMC initiatives, the regulations permit the submission of item 4 material 90 to 120 days in advance of other sections of the NDA (21 CFR 314.50(d)(iv)) as a further means of expediting the regulatory review process. 

Much from the integrated summaries described above may be reused in this report, with the exception of the expert, who must personally sign the report. Expert reports contain the expert s curriculum vitae, and part of the regulatory review process is to evaluate whether the expert is actually qualified for this role. The choice of expert is important, and his/her independence is crucial because the role is that of a reviewer and not of a sponsor. Experts may nonetheless be drawn from within the sponsoring company with appropriate protections, although those from outside may carry more credibility in some jurisdictions. 

Figure 19.1 Japanese regulatory review process. Flow of new drug application submission, review and approval. PAFSC, Pharmaceutical Affairs and Food Sanitation Council MHLW, Ministry of Health, Labour and Welfare.

On the other hand, some companies may collect more data than the FDA would require either because they are overly cautious or because the firm needs the data for other reasons (e g., approval in another country or to market the drug more effectively) such firms spend money to pursue research questions not germane to the regulatory review process. Thus, the costs of clinical research in the regulatory phase cannot be attributed in its entirely to regulations. 

Established specific time limits for industry and agency action at various points in the regulatory review process 19... 

Largely in response to the AIDS epidemic and the regulatory reform movement of the 1980s, the FDA issued new regulations, in 1988, known as Subpart E, that substantially alter the research and regulatory review process for drugs to treat... 

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