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    Home > Medical News > Medical World News > The EU publishes a question-and-answer guide on nitrosamine impurities, which provides recommendations for the evaluation, detection and mitigation of impurities.

    The EU publishes a question-and-answer guide on nitrosamine impurities, which provides recommendations for the evaluation, detection and mitigation of impurities.

    • Last Update: 2020-09-11
    • Source: Internet
    • Author: User
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    Extend the deadline for chemical risk assessment and add biopharmaceity assessment requirements.
    updated question-and-answer guide document issued by the European Medicines Agency (EMA) on August 6th provides listing licensees (MAH) with recommendations for the treatment of nitrosamine impurities.
    guidelines give MAH with a chemical synthesis API more time to evaluate the presence of potentially carcinogenic nitrosamine impurities in the product, and set a new deadline for MAH to perform similar evaluations of preparations containing the Biopharmaceous API.
    EMA's deadline for risk assessment of nitrosamine-related chemicals has now been extended to March 31, 2021, replacing the previous deadline of October 1, 2020.
    this risk assessment requirement is new for biologics and needs to be completed by July 1, 2021.
    this is the second time the deadline has been extended since the EMA requested a nitrosamine-related chemical risk assessment last September.
    the initial deadline for completing the risk assessment is March 26, 2020.
    the challenges posed by the COVID-19 pandemic, the EMA extended this period until October 1, 2020.
    the deadline for chemical risk assessment in the newly released question-and-answer guide has been extended until March next year.
    this was made after the EMA Human Drug Assessment Board (CHMP) concluded its review of nitrosamine impurities in June.
    CHMP review followed the release in July of the Nitrosamine Impurity Assessment Report, which concluded that some biological drugs may also be at risk of nitrosamine impurities and recommended that the risk assessment requirements be extended to biopharmaceasers.
    the risk of biological products containing chemically synthesized fragments is higher, risk factors similar to those of chemically synthesized API should be taken into account, as are biological products packaged in bubble packaging containing nitroculose.
    guidelines require MAH to follow a three-step process to identify and, where necessary, reduce the risk of nitrosamine impurities in all products containing chemically synthesized or bio-raw materials.
    MAH first needs to conduct a risk assessment to determine whether the API and the finished preparation are at risk of nitrosamine formation or contamination (cross contamination).
    MAH must use a dedicated template to report the results of the risk assessment to the relevant national authorities (for drugs assessed under national, decentralized and mutual recognition procedures) and the EMA (for medicines assessed under centralized procedures).
    if a risk is identified, the MAH must proceed with the second step and perform a confirmation test to confirm or refute the presence of nitrosamines and report the results as soon as possible.
    if nitrosamines are confirmed, effective risk mitigation measures must be implemented in the third step of the process by submitting the necessary change requests.
    in accordance with the new question-and-answer guidelines, the submission of confirmation testing activities for chemicals (step 2) and any changes to the listing permit application (step 3) should be completed by 26 September 2022 at the 6th of September 2022.
    for biopharmaceonceons, these activities should be completed by July 1, 2023.
    question-and-answer guide also details the production, handling and packaging processes known to increase the risk of nitrosamine contamination in the finished product.
    , however, the guidelines state that the list of issues is not exhaustive and that "MAH/applicants and drugmakers should include all potential sources of contamination or nitrosamine formation as part of the risk assessment."
    " question-and-answer guide also warns that nitrosamine thresholds for trace impurities mean that extra care must be taken when selecting analytical methods.
    mah should conduct control experiments and consider using orthosecting analysis methods.
    the specific requirements of the analytical methods used for testing.
    question-and-answer guide also lists the daily acceptable limits for various nitrosamines, no more than 96 ng/day, and only if a single nitrosamine impurity is identified.
    EMA has also developed priority options for product testing using a risk-based approach"MAH may take into account factors such as the maximum daily dose of the drug, the duration of treatment, treatment adaptation, and the number of patients receiving treatment.
    "drugs that require higher doses and long-term use per day may be prioritized for higher evaluation and testing."
    ICH Q9's guidance on quality risk management guides the prioritization process.
    question-and-answer guide describes the specific steps to be taken when nitrosamines are detected, including guidelines on measures to meet or fail to meet nitrosamine limits, including mitigation measures and reporting requirements.
    guide also covers the process of submitting changes for approved listing permit applications and the method of submitting new listing permit applications.
    regulators around the world are trying to solve the problem of nitrosamine impurities in the drug Central Asia.
    so far, elevated levels of nitrosamine impurities have been found in the antihypertensant sartans, the sugar-lowering drug metformin, the heart-burning drug renitridine and even the anti-tuberculosis drug Lyphosin.
    finishing: know the forest - pepper.
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