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17 November 2016, MHRA, Diane Leakey

Due to the rising volume of applications for Wholesale Dealer’s Authorisations (WDA), the Good Distribution Practice (GDP) inspectors have been developing a model for Office Based Risk Assessment (OBRA). OBRA will allow inspectors to remotely assess applications for WDA’s instead of conducting traditional site visits. The OBRA model was officially launched at the beginning of 2016 and has been used for the review of pharmacy collection sites. The new approach allows inspectors to prioritise their physical site visits on higher risk organisations and reduce inspection costs, protecting public health by effectively maintaining regulatory standards.

MHRA leading European action to reinforce market surveillance of medical devices to protect public health

17 November 2016, MHRA

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched the Joint Action on Market Surveillance of Medical Devices. The project aims to improve the market surveillance system for medical devices and improve the coordination and communication between the member states of the European Union. John Wilkinson, MHRA’s Director of Medical Devices, said that the MHRA is pleased to be leading the new initiative and are looking forward to collaborating with colleagues across the EU to reinforce market surveillance of medical devices.

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17 November 2016, MHRA, Diane Leakey

Traditionally, GDP (Good Distribution Practice) inspectors visit sites to confirm that holders of Wholesale Dealer’s Authorisations (WDA) are compliant with the requirements of legislation.

Over recent years the volume of applicants for WDA’s has increased significantly which has necessitated the introduction of risk based systems to ensure GDP Inspectorate resources are used to maximum effect.

As part of this project, work began last year on developing a model for Office Based Risk Assessment (OBRA); this was intended to allow inspectors to remotely assess applications for and variations to WDA’s.  Having been worked up and validated the model was introduced and is now being used for pharmacy collection sites.

Launch of the scheme

The scheme was officially launched in at the start of 2016 and is now fully bedded in.  In the first six months over 200 sites were assessed, covering nine companies. Had these assessments been undertaken in the ‘conventional’ way they would have required nearly 200 GDP inspector days on site.  Additionally, by assessing applications in this way the regulatory costs to applicants have been significantly reduced.

Site selection process

Assessments are initially being carried out on retail pharmacy sites that undertake the ordering and collection of medicines which are sent onto a central hub within the same organisation for onward supply to another wholesaler. In this model stock is ordered from a small number of wholesalers in excess of the pharmacy need, holding these products for a short while on the pharmacy premises and then selling on. The intention is not to use this type of assessment process to replace an actual inspection but to more adequately assess and understand the risks associated with pharmacy wholesaling sites of this type. The following criteria are used to judge suitable sites for inclusion in the programme:

• The site is undertaking limited activity: its purpose is the procurement of stock, with the stock being transferred to the company’s warehouse or head office and not directly to another customer outside the company’s ownership

• The company is known to have a good level of compliance with no major deficiencies in the last inspection cycle

• The company uses a common Quality Management System across the group and this has been assessed at inspection at the head office or central warehouse site which continues to be inspected on a normal risk based frequency.

• A GDP certificate for the site is not required – the lack of a GDP certificate does not prevent the wholesaler from trading at this site as the site is supplying the hub only

Assessment

Assessment is based on three inputs, the company’s answers to questions about the size and value of its wholesaling business, the quality of the company’s procedures together with the control and conditions of the site’s holding areas. An overall risk score is derived from these scores and the next risk review assessment set, based on the risk rating achieved.

Outcomes and benefits to both stakeholders and the MHRA

This new approach helps Inspectors focus their physical site visits on higher risk activities and operations, increase coverage of the inspection universe and helps to increase trust with stakeholders whilst at the same time reducing their inspection costs. It therefore clearly demonstrates how the Inspectorate continues to find innovative ways to address challenges and thereby continue to protect public health by effectively maintaining regulatory standards.

MHRA leading European action to reinforce market surveillance of medical devices to protect public health

17 November 2016, MHRA

The Medicines and Healthcare products Regulatory Agency (MHRA) has officially launched the Joint Action on Market Surveillance of Medical Devices.

Medical devices cover a wide range of products – from sticking plasters to hip replacements, from contact lenses to personal oxygen tanks and implanted pacemakers. These devices and others like them, can be found in every household across Europe, once they have been CE marked.

To make sure devices like these are acceptably safe and perform as intended, Competent Authorities need to have a strong programme of market surveillance.

On 19 October 2016, at the 39th meeting of the Competent Authorities for Medical Devices in Bratislava, Slovakia, MHRA officially launched the Joint Action on Market Surveillance of Medical Devices.

The project aims to reinforce the market surveillance system for medical devices by improving the coordination of activities by all member states of the European Union, and ensuring adequate communications and cooperation. These are crucial for success and effectiveness of the market surveillance in the field of medical devices.

The Joint Action supports the Consumers, Health, Agriculture and Food Executive Agency’s (Chafea) programme of community action in the field of health to deliver against one of its objectives: to contribute to innovative, efficient and sustainable health systems.

Chafea is entrusted by the European Commission to implement the health programme and EU Members States involved in the programme – in January 2016.

John Wilkinson, MHRA’s Director of Medical Devices, said:

We are pleased to be leading this important activity and look forward to working with our colleagues across the EU in delivering improvements to reinforce market surveillance.