News

No comparative efficacy study required for Heparin biosimilars

The EU guideline, dated 10th November 2016, on non-clinical and clinical development of similar biological medicinal products containing low-molecular-weight-heparins states that “pivotal evidence for similar efficacy will be derived from the similarity demonstrated in physicochemical, functional and pharmacodynamic comparisons.” As such a comparative efficacy trial is not necessary.

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MHRA and HTA sign agreement

On 8th December 2016, the Medicines and Healthcare products Regulatory Agency (MHRA) and the UK Human Tissue Authority (HTA) signed a partnership agreement strengthening their existing collaboration. The agreement should see a strengthening of the working relationship between the two bodies.

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FDA publishes draft guidance for submitting pharmacokinetic modelling analyses

The US Food and Drugs Administration (FDA) has outlined recommendations for submitting physiologically based pharmacokinetic (PBPK) analysis data to support regulatory applications. The new draft guidance describes the preferred format and content for a sponsor to submit PBPK analyses to support INDs, NDAs, BLAs and ANDAs. A previous lack of regulatory guidance has meant that the content and presentation of submitted PBPK analyses varied greatly. It is hoped that the new guidance will deliver a standard approach, in turn helping FDA be more efficient and timely with their reviews.

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FDA finalises guidance on the Clinical Pharmacology section of labelling

The US Food and Drug Administration (FDA) finalised its guidance for the content and format of the clinical pharmacology section for human medicine and biological product labelling. The guidance described the data required for the clinical pharmacology section of the labelling for drugs, biologics and generics for new submissions and amendments. The final version of the guidance is much the same as the previous draft, although the document has been significantly rewritten and contains some new information. One new section clarifies that companies do not need to submit a labelling supplement just to make a minor formatting change, i.e., it is not a change driven by a regulatory requirement or a safety issue. Minor formatting changes should be included in the product’s next annual report.

To access the guidance, please click here.

TGA publishes information on varying entries in the ARTG for medical devices and IVDs

On 30th November 2016, the Australian Therapeutics Goods Administration (TGA) published a guidance to companies to keep information included in the Australian Register of Therapeutic Goods (ARTG) up-to-date. The ARTG is a searchable record of the contents and classification details of therapeutic goods that can be supplied in Australia. The search function can be used for medicines and medical devices. The publicly accessible version of the ARTG can be found here.

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API GMP inspections collaboration to include Japan

Japan has joined the existing international collaboration on good manufacturing practice (GMP) inspections for active pharmaceutical ingredients (APIs). The Japanese Pharmaceutical and Medical Devices Agency (PMDA) will collaborate with EMA, EU Member State authorities, the European Directorate of the Quality of Medicines and Healthcare (EDQM), the United States Food and Drug Administration (FDA), the Therapeutic Goods Administration (TGA) in Australia, Health Canada and the World Health Organization.

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Public consultation on the increase of fees in medical devices activities by the MHRA

The MHRA is seeking feedback from interested parties on its proposal for increasing and addition of fees in its medical devices activities.
Currently, the MHRA charges fees for auditing and designating notified bodies, registering class I medical devices and authorising clinical investigations with medical devices.
The current fees have not increased since 2010 despite the increased workload generated by some changes in the regulation for notified bodies surveillance. Currently, the collected fees do not recover MHRA’s cost for these services. The shortfall is being subsidised by the Department of Health.

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US FDA guidance on safety testing of drug metabolites revised

The US Food and Drug Administration (FDA) recently released revised guidance on recommendations on when and how to evaluate the nonclinical toxicity of drug metabolites. The revisions mean the new guidance is now aligned with the ICH M3(R2) Nonclinical Safety Studies guideline. The guidance represents the consensus that exists regarding the type and duration of nonclinical safety studies and their timing to support the conduct of human clinical trials and marketing authorisations for pharmaceuticals.

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