Fda releases 2021 guidelines work plan to lead new regulatory developments

In January 2021, the FDA continued to uphold the principle of open and transparent work by publishing the 2021 CDER Guideline Revision and Development Work Plan CDER Guidance Agenda-New and Revised Draft Guidance Planned for Publication in Calendar Year 2021.
this annual work plan, it can be seen that the FDA will initiate the revision and development of the guidance document in a number of regulatory areas, and further affect the international pharmaceutical industry.
through the overall interpretation of this document and key interpretation, I hope to provide reference for Chinese pharmaceutical colleagues.
Part I: The overall work schedule of the 2021 Guidelines According to the work plan of this guide, we can see that in 2021, the FDA will initiate revisions and development plans for multiple guidance documents in a number of areas.
information is combed in the table below: according to the table above, the FDA is expected to revise and develop 105 guidelines in fiscal 2021;
Part II: Key Guidelines and Domain Introductions : Biosyspolytes continue to be of concern as health care costs continue to rise in the U.S., and the FDA wants to reduce the pressure on health care costs by driving biosynthic drugs to market.
but because the FDA has a stricter policy on the use of biosynthic drugs, a biosypole cannot be used directly and in alternative biologics when approved.
biosynthics to replace the compared biologics, they must be developed and declared in accordance with the requirements of Interchangeable Biological Products before they can be interchangeable for clinical use of the participating biological products after approval.
to guide the industry in developing biosimilars and interchangeable biologics, the FDA will issue guidelines for Product Class-Specific Recommendations for Developing Biosimilar and Interchangeable Biological Products, which will provide regulations for the technology.
. In order to guide pharmaceutical companies to choose a reasonable dose of a drug in clinical research and development, the FDA will release Dose Selection in Drug Development to explain this issue;
addition, drugs are often used clinically in complex environments, where multiple drugs are shared.
to guide companies in assessing the risks of multidring sharing, the FDA will issue guidelines for Drug-Drug Interaction Assessment for Therapeutic Proteins to explain the ideas.
a number of work in the field of generic drugs worthy of attention first, in order to guide pharmaceutical companies to improve the quality of reporting, in the past the FDA has issued three RTR guidelines.
in this latest work plan, the FDA will continue to issue two RTR guidelines: ANDA Submissions - Refuse-to-Receive for DMF Facilities Anders Anda Submissions - Refuse-to-Standards: Questions and Answers.
no doubt that these guidelines, known as the shootout clause, are bound to cause concern in China's pharmaceutical industry.
, the concept of generic consistency will be reinforced and interpreted in depth.
China has been launching more than 6 years of consistent evaluation project is actually the wrong topic, should not be called "quality and efficacy consistency", but should be called "efficacy consistency evaluation", because generic drug quality properties can be inconsistent with the quality attributes of the drug.
For oral generic preparations, in order to prove the efficacy of generic and compared drugs, BE tests can be used, and even the use of proven clinical evidence of consistency; The FDA's new guidelines, Evaluation of Therapeutic Equivalence, provide the latest recognition.
, the Q3 characteristics of skin medication will be given the latest awareness.
in injection consistency evaluation, the industry generally recognizes that the Q1/Q2 standard is at least met, and in some special drugs, the Q3 standard is also mentioned.
the FDA guidelines for how skin medications judge Q3 and how Q3 affects research and development decisions on skin medications, FDA guidelines Physico-Structural (Q3) Will provide the latest answers in Topical Dermatological Drug Products in ANDAs.
the latest changes in GMP management, the FDA will revise PET Drugs - Current Good Manufacturing Practice (CGMP) to update the GMP management requirements for PET products.
, the drug industry's continued concerns about cross-contamination have prompted the FDA to respond by revising Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Prevention Cross-Contamination.
latest trends in the CMC field are the focus of drug development and post-market management, and the FDA will release ANDAs: AndAs: Stability Testing of Drug Substances and Products Questions and Answers to explain this issue in depth.
ICH Q12 guidelines primarily manage post-market changes to medicines.
if a pharmaceutical authority actively implements the management ideas of ICH Q12, it should make the changes after the drug market more reasonable and humane.
, japan and the FDA are actively building teams to facilitate the implementation of ICH Q12.
the FDA will release ICH Q12, General View for FDA Implementation to explain its latest approach to the issue.
visible foreign objects are the key quality properties of injection products and the key factors affecting drug safety.
the FDA will release Inspection of Injectable Products for Visible Financials to strengthen oversight of the issue.
the quality of oral drugs microbial properties control for oral drugs, do not need to detect microbial limits? What needs to be tested? How are test standards scientifically set? The FDA will release Microbiological Quality Products In Non-Sterile Drug Product Manufacturing to explain the problem.
the application of real-world evidence as pharmaceutical regulators around the world issue real-world evidence regulations, the FDA has clarified similar issues.
2021, the FDA will release two guidelines for Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products, and Regulatory Management for The Use of Real-World Data and World Evidence to Supporty Decision-Making for Drugs and Biological Products, giving more specific guidance on this issue.
the above introduction and analysis, it can be seen that in 2021, the FDA will update regulatory requirements and ideas in a number of areas.
chinese companies working to expand into the U.S. market are actively researching to prepare for the latest regulatory requirements.
also hopes that these latest technical guidelines will facilitate work in China's pharmaceutical industry.