BioPharm International - September 2019

BioPharm - Regulatory Sourcebook

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Page 8 of 44 September 2019 BioPharm International eBook 9 Regulatory Sourcebook Regulatory Guidance Update under medical device application types or to labeling intended for use by healthcare providers. It also does not apply to devices regulated under a BLA, such as devices associated with blood collection and processing procedures. PHARMACOPEIA UPDATES FDA released draft guidance on July 10, 2019 that assists applicants in initiating revisions to an existing monograph or the development of a new monograph under the United States Pharmacopeial Convention– Pending Monography Process (USP– PMP) during FDA's evaluation of a drug substance master file or drug product application (7). Applicants of drug approvals must comply with USP National Formulary (NF) stan- dards, if applicable. The guidance assists these applicants in using the USP–PMP to request a revision of compendial standards. In the past, if proposed specifica- tions in a drug application appeared to not comply with the current USP monograph, FDA approval of the application would be delayed. Until the USP–PMP was established, there was not a process for drug develop- ers to request changes to compen- dial standards for products that were not yet approved by FDA. This draft guidance describes the process for the "revision of compendial stan- dards that are harmonized with the approved quality and labeling requirements for a drug product application," including how to initi- ate the USP–PMP process. QUALITY REGULATIONS FDA made M10 Bioanalytical Method Validation available in June 2019 (8). The draft guidance, developed by the International Council for Harmonization (ICH), is intended to provide recommendations for the validation of bioanalytical assays for chemical and biological drug quan- tification and their application in the analysis of study samples. The guid- ance describes the various elements and expectations to validate specific tests used to measure the parent and active metabolites of drugs admin- istered in nonclinical and clini- cal studies submitted in regulatory applications for biological matrices such as plasma, blood, or serum. BIOSIMILARS On May 21, 2019, FDA published guidance on the design and eval- uation of comparative analytical studies used to support the bio- similarity of a proposed therapeu- tic protein product to a reference product licensed under section 351(a) of the Public Health Service Act (PHS Act) (9). The guidance also offers recommendations on the scientific and technical infor- mation for the chemistry, manu- fac t ur ing, and controls (CMC) portion of a marketing applica- tion for a proposed product sub- mitted under section 351(k) of the PHS Act. Among an overview of the PHS Act and the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), the guidance specifically discusses expression systems, manufacturing processes, physicochemical properties, func- tional activities, target binding, impurities, reference products and standards, f inished dr ug prod- ucts, and stability. Considerations addressed for a comparative ana- lytical assessment include refer- ence and biosimilar products and data analysis. T he g u id a nc e i s p a r t o f a ser ies of doc u ments to fac i l i- t a t e t h e i m p l e m e n t a t i o n o f t he BPCI Ac t. Ot her g u ida nce d o c u me nt s a d d r e s s s c ie nt i f ic considerations, biosimilar devel- opment, clinical pharmacolog y data, labeling of biosimilars, and demonstrating interchangeability. REFERENCES 1. FDA, FDA Patient-Focused Drug Development Guidance Series for Enhancing the Incorporation of the Patient's Voice in Medical Product Development and Regulatory Decision Making,, development-approval-process-drugs/ fda-patient-focused-drug-development- guidance-series-enhancing-incorporation- patients-voice-medical 2. FDA, Rare Pediatric Disease Priority Review Vouchers Guidance for Industry, Draft Guidance (CDER, July 2019), www. 3. FDA, Providing Regulatory Submissions in Electronic Format—Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for Industry, Draft Guidance (CDER, CBER, July 2019), www. fda-guidance-documents/providing- regulatory-submissions-electronic-format- certain-human-pharmaceutical-product- applications-0 4. FDA, Population Pharmacokinetics, Guidance for Industry, Draft Guidance (CDER, CBER, July 2019), www.fda. gov/regulatory-information/search- fda-guidance-documents/population- pharmacokinetics 5. FDA, Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry (CDER, CBER, July 2019), information/search-fda-guidance- documents/risk-evaluation-and- mitigation-strategies-modifications-and- revisions-guidance-industry-0 6. FDA, Instructions for Use—Patient Labeling for Human Prescription Drug and Biological Products and Drug- Device and Biologic-Device Combination Products—Content and Format Guidance for Industry (CDER, CBER, July 2019), search-fda-guidance-documents/ instructions-use-patient-labeling- human-prescription-drug-and-biological- products-and-drug-device 7. FDA, Harmonizing Compendial Standards With Drug Application Approval Using the USP Pending Monograph Process Guidance for Industry, Draft Guidance (CDER, CVM, July 2019), media/128689/download 8. FDA, M10 Bioanalytical Method Validation (June 2019), information/search-fda-guidance- documents/m10-bioanalytical-method- validation 9. FDA, Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations Guidance for Industry (CDER, CBER, May 2019), www.fda. gov/regulatory-information/search-fda- guidance-documents/development- therapeutic-protein-biosimilars- comparative-analytical-assessment-and- other-quality BP

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