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    EMA proposes quality guidelines for synthetic peptides and oligonucleotides

    The European Medicines Agency (EMA) want to set clear quality guidelines for drug companies manufacturing synthetic peptides and oligonucleotides.   EMA raised the idea of specific guidelines for such products in new concept papers published this week, explaining current requirements on impurities testing, specifications and the control of DNA-reactive chemicals either partly or fully exclude synthetic peptides and oligonucleotides.   According to the agency, the p...
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    FDA issues final rule on ‘right to try’ reporting requirements

    Drug firms that agree to supply investigational medicines under the Right to Try Act must submit an annual summary detailing each use to FDA under a final rule issued this week.   The final rule specifies that manufacturers include details of the number of doses supplied, the number of patients treated, the use for which the drug was made available and any known serious adverse events that take place.   The rule also establishes when manufacturers need to submi...
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    EMA: Pilot bringing ex-EU regulators to COVID product meetings was a success

    Involving non-EU regulatory authorities in the assessment of COVID-19 vaccines and therapies helped regulators accelerate and align on decisions, according to a new report from the European Medicines Agency (EMA).   EMA made the comments in a review of the OPEN (Opening our Procedures at EMA to Non-EU authorities) initiative also reporting that it “had enhanced communication channels and facilitated discussions and exchanges.”   The OPEN programme – which debuted...
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    MDCG sets out transition periods for legacy diagnostics post-IVDR

    The European Commission’s Medical Device Coordination Group (MDCG) has clarified how long legacy devices can remain on the market after the In Vitro Diagnostic Regulation (IVDR) comes into application.   The new timelines are set out in a guideline covering legacy devices that are placed on the market before May 26, which is the date the transition period from the current IVD Directive (IVDD 98/79/EC) ends.   A legacy device is either: a device with an EC certifi...
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    MDCG guidance clarifies permitted changes to devices launched ahead of IVDR

    Manufacturers that bring devices to market ahead of the In Vitro Diagnostic Regulation (IVDR) have a clearer idea of the changes they can make to products thanks to new guidance.   The IVDR is due to come into application on May 26.   Until then, and for a limited period thereafter, device manufacturers can place in vitro diagnostics on the market with certificates issued under the old directive under a transitional provision adopted by the Council of the European ...
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    MDCG issues guidance to help define ‘borderline’ products

    Developers struggling to decide whether their products are drugs or devices now have clearer definitions thanks to new guidance issued by the European Commission’s Medical Device Coordination Group (MDCG).   In general, determining whether a product is a device covered by the Medical Devices Regulation 2017/745 or a medicine covered by Directive 2001/83/EC on the Community code relating to medicinal products for human use (MPD) is straightforward.   For other pro...
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    EMA, HTA consortium prep for HTA regulation coming into effect

    The European Medicines Agency (EMA) and the European Network for Health Technology Assessment (EUnetHTA) 21 consortium have outlined the next stages of their preparation for the EU Regulation on Health Technology Assessment.   The organisations shared details this week in a new work plan covering efforts through 2023, explaining that the overall aim is to find synergies that facilitate patients' access to innovative medicines in the European Union (EU).   EMA sai...
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    Drug industry says EMA’s PRIME scheme useful but could be improved

    Eligibility criteria for admission to the European Medicines Agency’s (EMA) priority medicines (PRIME) scheme are too strict to facilitate innovation in Europe according to the European Federation of Pharmaceutical Industries and Associations (EFPIA).   The drug industry group made the comments to Regulatory Focus in response to the publication of a report on the first five years of the PRIME scheme. (RELATED: EMA lauds PRIME priority meds scheme and outlines pot...
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    EMA lauds PRIME priority meds scheme and outlines potential revisions

    Eighteen medicines for previously unmet needs are available due of the PRIME (PRIority MEdicines) scheme according to the EMA, which plans to optimise the programme to ensure developers get the support they need.   The EU regulator made the comments in a review published this week that looked at the impact of the scheme since its launch in 2016 (RELATED: EMA Looks to Accelerate New Therapies Targeting Unmet Needs , Regulatory Focus 07 March 2016).   Ten of the...