|Date:||09 Mar 2009|
|Subject:||More efficiency in handling non-prescription medicines thanks to creation of new assessment team|
|Contact:||Press Office 020 3080 7651
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The Medicines and Healthcare products Regulatory Agency (MHRA) is set to welcome a new Product Lifecycle Assessment Team (PLAT) to the Licensing Division.
The dedicated assessment team will primarily focus on processing non-prescription products and will handle both new applications as well as non-safety related variations.
Since the introduction of the Decentralised Procedure (DCP) for processing Marketing Authorisation Applications (MAA) in late 2005, the United Kingdom has been a major Member State contributing to the assessment of these types of applications in the European Regulatory Network (ERN).
MHRA Deputy Director of Licensing, Dr Siu Ping Lam said the number of DCP procedures where the UK acted as the Reference Member State (RMS) has increased significantly year upon year.
“And in response to this, we have increased our assessor resources considerably and introduced a number of process improvements.”
Nevertheless the increasing use of the DCP, together with the associated fixed timings, has presented a challenge to the MHRA to ensure national procedures, including many non-prescription medicines, are assessed as efficiently as possible.
Dr Lam said the MHRA recognised this area of service required improvement and by establishing the new assessment team UK non-prescription product applications will be handled a lot more efficiently.
“The creation of a new PLAT together with the expansion of assessment capacity over recent years reflects the UK’s commitment to both national medicines regulation and support to the ERN for the benefit of public health,” he said.
“It also demonstrates the MHRA is responsive to the needs of the pharmaceutical industry and that we are committed to improving the level of service delivery to all areas of industry, whilst maintaining high standards of assessment.”
Notes to Editor
The UK is a leading RMS for DCP
- The DCP was introduced in late 2005 and since then the number of MAAs for medicinal products processed using this route has increased significantly.
- It is now the predominant procedure for pharmaceutical companies in the European community to launch their products.
- In 2005, the total number of procedures started in the European community using the Mutual Recognition Procedure (MRP) or the DCP was 907. By 2008 that total had more than doubled to 1896, 77% of this figure was due to DCP.
- The UK has made major contributions to the European Regulatory Network for the processing of MAAs submitted either via the MRP or the DCP procedures.
- In 2008, the largest number of DCP procedures was started by the UK as RMS who led the assessments, representing 28% of the total European community DCP procedures.
The UK has made substantial investment in assessor resource
- In the recent years the MHRA’s workload has increased in most areas. In response, the MHRA has expanded assessment capacity. In the two years between March 2006 and March 2008, the assessor resource in the Licensing Division was increased by 40% to 105 assessors. A further 19 assessors also started the year from March 2008.
- Additional assessors will also be joining the Agency from March 2009.
The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem. We encourage everyone –the public and healthcare professionals as well as the industry – to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action. www.mhra.gov.uk