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  • Regulatory NewsRegulatory News

    EMA Offers Q&A on Exemptions From Batch Re-Testing for Imported ATMPs

    The question and answer (Q&A) document released by the European Medicines Agency (EMA) on Wednesday describes when an exemption from EU batch re-testing can be granted for imported advanced therapy medicinal products (ATMPs). The three-page Q&A begins by noting that a Qualified Person (QP) has to ensure each batch of imported ATMP is re-tested upon importation. But the QP can certify that the imported batch relies on controls conducted in a third country if the product ...
  • Regulatory NewsRegulatory News

    EC Reiterates: All Batch Testing Must be Transferred From UK to EU by 2020

    The European Commission (EC) said recently that all marketing authorization holders (MAHs) need to ensure that all work at batch testing facilities in the UK is transferred to EU facilities and that all the necessary regulatory submissions are completed by 1 January 2020. The reminder announcement follows a letter sent last February that said drugmakers under certain circumstances would be allowed to continue batch testing in the UK even after the UK departed from the...
  • Regulatory NewsRegulatory News

    European Commission and EMA Offer Guidance on Brexit for Pharma Companies

    As marketing authorisation holders (MAHs) based in the UK begin to form plans to transfer their marketing authorizations (MAs) to holders established in the EU, Norway, Iceland and Liechtenstein, the European Medicines Agency (EMA) and European Commission on Wednesday released guidance to prepare industry for the UK’s withdrawal from the EU. The question and answer document is the first in a series of guidances and follows a notice sent earlier this month to ...
  • Regulatory NewsRegulatory News

    FDA Allows First Switch From Batch to Continuous Manufacturing for HIV Drug

    The US Food and Drug Administration (FDA) for the first time in its history allowed a manufacturer to switch from the more antiquated batch manufacturing process to a continuous manufacturing process – a move that FDA is seeking to encourage among more pharmaceutical manufacturers. The manufacturing change, announced last Friday, is for Janssen’s HIV-1 treatment Prezista (darunavir). And although Janssen isn’t the first manufacturer to use continuous manufacturing (Verte...
  • DEA Classifies Bath Salt Chemical as Schedule I Drug After Oversight

    • 18 October 2012
    The Drug Enforcement Administration (DEA) has placed methylone, a powerful stimulant and psychoactive drug most notorious for its presence in bath salts, into its Schedule I of highly restricted drugs with no accepted medical use within the US. The drug is chemically similar to other drugs like Ecstasy (MDMA), which has been a Schedule I drug under the Controlled Substances Act (CSA) since 1985. DEA's actions would act to put into place a more permanent solution, o...
  • Analysis: FDA Warning Letters in 2011 Mostly Focused on Batch Failures

    An analysis of US Food and Drug Administration (FDA) warning letters issued in 2011 shows the majority of all facilities receiving a warning letter were deficient in areas relating to batch failure investigation , reports In-Pharma Technologist . "In the manufacturing-related warning letters analyzed by in-Pharma Technologist, FDA made 211 numbered observations," of which 10% were related to the company not investigating batch failures. Despite only 10% of all obs...
  • Report, Guideline on Target Animal Batch Safety Test for Vaccines Released by EMA

    The European Medicines Agency (EMA) released a report and a guideline on 23 January about target animal batch safety tests (TABST) for veterinary vaccines. EMA has been trying to implement a waiver system for TABST requirements for marketing authorization holders (MAHs), but has received significant pushback from companies claiming that the waivers aren't worth their time. The report highlights their concerns, while the guideline revises the data requirements necessar...