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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Regulis wins new medical device client

We are pleased to announce that we have secured a new medical devices client. This engagement will begin with one of Regulis’ expert auditors conducting an audit against ISO 13485. This will ensure the company fulfils its obligations to have performed an internal audit and that the company is ready for its Notified Body inspection.

If you require help with an internal audit or any other aspects of medical devices registration, please contact our Medical Devices team via our Contact Us page.

EMA issues updated guidance on Type II variations and marketing authorisation extensions for orphan medicines

Following publication of guidance on the application of the Orphan Regulation by the European Commission, the European Medicines Agency (EMA) has issued updated guidance to companies providing them with details of the information that need to include in a Type II variation or marketing authorisation extension for an orphan-designated medicine.

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Public consultation on the EU Paediatric Regulation

The European Commission (EC) is consulting on the Paediatric Regulation seeking feedback from stakeholders and interested parties. The information and views received will help the Commission prepare its second report on the Regulation, assessing the impact of the Paediatric Regulation on public health and the pharmaceutical industry. The final report is expected sometime in 2017.

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2016 TOPRA Awards

The TOPRA Awards for Regulatory Excellence are given to outstanding individuals and teams in regulatory affairs. The awards, established in 2010, are to reward excellence, wherever it may occur in regulatory affairs and to recognise the achievement of individuals, teams and organisations both within TOPRA and the wider regulatory affairs community. The judges, all respected figures in the regulatory industry, had the difficult job of whittling the entries down to just three in each category.

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Guidance on exporting medical devices from the UK

The MHRA published information this week reminding medical device companies doing business abroad that they should check if they need a certificate to export their medical devices.

To export to countries outside the EU, companies may require a Certificate of Free Sale (CFS). A certificate is not required to supply medical devices within the EU.

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Social media campaign to promote adverse drug reaction reporting


During the week beginning 7th November, the Medicines and Healthcare products Regulatory Agency (MHRA) is running a social media campaign to promote the reporting of suspected side effects. This initiative is part of the Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) Joint Action project. One of its main aims is to raise awareness of national reporting systems for suspected side effects in medicines. Over 20 member states are taking part in the combined cross-European social media campaign.

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