Part II: Analysis on Important Topics
2.1 Biopharmaceutics
FDA will publish three guidances on biopharmaceutics, separately being Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations (Revised Draft), Bioanalytical Method Validation (Revised Draft) and Bioavailability Studies Submitted in NDA’s or INDs for Orally Administered Drug Products – General Considerations (Revised Draft). Drafts of these three guidances have been issued in 2016, and FDA’s main task for them in 2017 is to gather the industry feedback information and make revisions. It should be mentioned that these 3 guidances will greatly affect Chinese enterprises which are conducting consistency evaluations.
2.2 Biosimilarity
FDA will publish 2 guidances in the biosimilar field in 2017, separately being Considerations in Demonstrating Interchangeability with a Reference Product and Statistical Approaches to Evaluation of Analytical Similarity Data to Support a Demonstration of Biosimilarity. It should be mentioned that the establishment of the current biosimilar regulations of China has used many FDA technical guidances for reference. The above two guidances will be of strong guiding significance to the groping Chinese biosimilar R&D and reviews.
2.3 Electronic Submissions
According to information available, the electronic submission requirement has been fully established and implemented among the European and American drug administration systems. CFDA will initiate the exploration efforts of electronic submission, according to CFDA annual meeting information. Guidances involving electronic submission that FDA is to draft in 2017 include Standardized Format for Electronic Submissions of NDA and BLA Content and Planning and Conduct of Bioresearch Monitoring Inspections, Providing Regulatory Submissions in Electronic Format – Submission of Manufacturing Establishment Information, Providing Regulatory Submissions in Electronic Format – Bioanalytical Methods Data Standards and Providing Regulatory Submissions in Electronic Format – Standardized Bioanalytical Data.
2.4 Generics
FDA plans to revise or newly draft 13 guidances in generics, which will be of enormous significance to Chinese pharmaceutical enterprises that mainly engage in generic drug development. And it will be a key point to study and learn those guidances for Chinese pharmaceutical enterprises that constantly intend to develop the U.S. market. Wherein, some guidances are quite interesting, for example, 180-Day Exclusivity: Questions and Answers will give detailed answers to the administrative exclusivity issue of first-time generic drugs; Chinese pharmaceutical enterprises should study carefully ANDA Submissions – Content and Format of Abbreviated New Drug Applications (Revised Draft); Determining Whether to Submit an Application Under 505(b)(2) or 505(j) will help Chinese pharmaceutical enterprises get familiar with several different types of ANDA submissions; Submission of ANDAs for Certain Highly Purified Synthetic Peptide Drug Products will provide FDA’s considerations in review of generic drugs of peptide pharmaceutical products.
2.5 Pharmaceutical Quality/CMC
FDA plans to revise or draft 11 guidances in Pharmaceutical Quality/CMC, which need to be paid attention to by practitioners engaging in the pharmaceutical research in pharmaceutical product development, wherein, Container Closure Systems for Packaging Human Drugs and Biologics (Revised Draft) will raise new requirements for pharmaceutical industry’s research of pharmaceutical product packaging compatibility issue, which should also be focused on by Chinese pharmaceutical product packaging material industry; the other key document is Drug Master Files (DMF) (Revised Draft), which indeed needs revising, as the last edition DMF was issued in 1987; Drug Products, Including Biological Products, That Contain Nanomaterials will show FDA’s R&D points for s...
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