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    Home > Medical News > Latest Medical News > After the new drug was approved for market, the requirements and research commitment: how much is it to achieve a thousand dollars?

    After the new drug was approved for market, the requirements and research commitment: how much is it to achieve a thousand dollars?

    • Last Update: 2020-09-05
    • Source: Internet
    • Author: User
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    What is the difference between PMR and PMC among FDA-approved drugs approved by the FDA in 2014-2019, accelerating the trend of approval channel changes (source: Data Source: Reference: Drug Mingkang content team drawings)? Post-market requirements (PMRs) refer to research or clinical trials that the applicant should conduct after approval, as required by laws and regulations, and post-market commitment (PMC) means that the applicant has agreed in writing to conduct research or clinical trials without legal and regulatory requirements.
    PMR and PMC may be released when a drug or biological product is approved or after approval.
    THE FDA classifys PMR/PMC as open (pending, ongoing, delayed, submitted or terminated) or closed (realized or dismissed) and classifys it according to the date on which the applicant achieved the original schedule progress node.
    who are subject to PMR/PMC must submit an Annual Status Report (ASR) within 60 days of the initial approval date of the product.
    be submitted in accordance with the alternate reporting schedule, either with or with FDA approval.
    you have to do a thousand dollars? The FDA's FY19 PMR and PMC reports show that, as with FY18 reports, most PMRs/PMCs "have successfully completed the schedule progress (completed) or are in the process of being completed."
    " FDA said that as of September 30, 2019, a total of 239 holders had 597 new drug applications (NDAs) requiring PMR/PMC, and a total of 95 holders had 173 applications for biological products licensing (BLA) requiring PMR/PMC.
    table 1. The number of NDA and BLA holders of the open PMR/PMC and the number of NDA BLA applications involved (source: References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
    , 395 (77 per cent) of the 515 annual status reports (ASRs) for the NDA were submitted on time;
    for BLA, 87 per cent (135/155) were received on time and the remaining 13 per cent were received late.
    THE FDA says that together, 79 percent of the PMRs of the open NDA and BLA and 75 percent of the PMC are proceeding as planned, and half of the outstanding open PMRs are listed as pending (46 percent of the open NDA PMRs, compared with 36 percent of the open BLA PMRs).
    by the end of fiscal 2019, 22% (238/1068) of the open NDA PMR and 18% (57/315) of the published BLA PMR have deviated from schedule.
    , almost all of the off-schedule NDA PMRs were delayed, only six were terminated, and all 57 off-schedule BLA PMRs were delayed.
    FDA report notes that most open PMCs go ahead as planned, with 72% (124/173) of NDA PMCs and 78% of BLA PMCs (143/184) going ahead as planned.
    , as with PMR, a large portion of the planned NDA and BLA PMC (38% and 25%, respectively) is in progress.
    pmC for most off-schedule drugs and biologics was delayed, with only three NDA PMCs and one BLA PMC terminated.
    the FDA reported that most PMRs and PMCs closed in FY19 met the requirements, while BLA PMR/PMC had a higher performance rate than the NDA's PMR and PMC.
    according to FDA requirements, 64% (114/117) of NDA PMRs have been completed in fiscal 2019, while 8% have been lifted and revised requirements have been made, and 27% have been lifted because the requirements are not workable or the product has been withdrawn.
    81% (29/36) of the NDA PMC closed in FY19 met the requirements.
    From the BLA's point of view, 89% of closed PMRs and 93% of closed PMCs have been completed, while the rest of the de-release status is due to reasons such as no longer feasible requirements or product recalls.
    it is significant that the implementation of PWR and PWC is equivalent to the addition of essential insurance to the approval of new drugs and biological products.
    references: . . . . . . . . . . . . . . . . . . . . . The Food and Drug Administration Report on The Performance of Drugs and Biologics Firms in Conducting Postmarketing Requirements and Commitments Fiscal Year 2019. Retrieved Aug 7, 2020 from .2, Asher Mullard. 2019 FDA drug approvals. Nature Reviews Drug Discovery. v19, Feb 2020, p79-84 . Acelerated Approval. Jan 4, 2018. Retrieved Aug 7, 2020 from s4 s 21 CFR 314. Subpart H. Retrieved Aug 7,2020 from .5. Michael Mezher. FDA: Most postmarketing requirements, commitments progressing on schedule. Aug 6, 2020. Retrieved Aug 7, 2020 from.
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