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Regulatory Focus™ > News Articles > MHRA to Pilot Stand-Alone Pharmacovigilance Inspections for Contractors

MHRA to Pilot Stand-Alone Pharmacovigilance Inspections for Contractors

Posted 13 August 2015 | By Michael Mezher 

MHRA to Pilot Stand-Alone Pharmacovigilance Inspections for Contractors

The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) is considering conducting "stand-alone" inspections of companies that conduct pharmacovigilance activities on a contractual basis for drugmakers.


Pharmacovigilance is the process of monitoring the use of drugs after they have entered the market. In particular, regulators, companies and healthcare providers are responsible for monitoring drugs and reporting suspected adverse events. This information is incredibly important to ensuring patient safety after a product has been approved.

The primary legal basis for pharmacovigilance requirements in the EU are found in Article 57 of Regulation (EC) No. 726/2004 and Title IX of Directive 2001/83/EC. In 2010 and 2012, the EU introduced new directives and regulations amending its pharmacovigilance requirements, which are collectively known as the new pharmacovigilance legislation.

MHRA and Pharmacovigilance

MHRA has been conducting pharmacovigilance inspections since 2003, when the agency introduced a new inspection program.

After the passage of the EU pharmacovigilance legislation in 2010 and introduction of new good vigilance practice (GVP) guidance, MHRA says its "remit to inspect organisations that provide contract services for pharmacovigilance" was strengthened. The agency cites Article 111 of Directive 2010/84/EU, which grants competent authorities the power to "inspect the premises, records, documents and pharmacovigilance system master file of the marketing authorisation holder (MAH) of any firms employed by the MAH to perform the activities described in Title IX."

Title IX reads:

It is necessary from a public health perspective to complement the data available at the time of authorisation with additional data about the safety and, in certain cases, the efficacy of authorised medicinal products. Competent authorities should therefore be empowered to impose on the marketing authorisation holder the obligation to conduct post-authorisation studies on safety and on efficacy. It should be possible to impose that obligation at the time of the granting of the marketing authorisation or later, and it should be a condition of the marketing authorisation. Such studies may be aimed at collecting data to enable the assessment of the safety or efficacy of medicinal products in everyday medical practice.

Stand-Alone Inspections

MRHA says it recognizes there are many different ways companies conduct pharmacovigilance activities. While some companies conduct all such activities in house, others outsource some or all of their pharmacovigilance responsibilities to third party service providers.

However, in the current situation, MRHA inspects pharmacovigilance contract service providers while conducting pharmacovigilance inspecting of individual MAHs. This means that an individual pharmacovigilance contract service provider "may be reviewed multiple times, depending on the number of MAHs who have subcontracted activities to that company." These inspections are covered under the fees charged to MAHs.

Now, MHRA is proposing a fee-based system for inspecting pharmacovigilance service providers. The agency says this system could benefit both it and the service providers it inspects. Some of the potential benefits include:

  • "a possible reduction in the number of times a service provider would be inspected"
  • "the frequency for each MAH to individually audit their service providers, as part of the MAH's risk-based audit programme, may be reduced if stand-alone inspections of service providers are conducted by the MHRA"
  • "possible allocation of MHRA resource where required in a risk-based fashion (as currently happens for MAHs) – it may be possible to cover the activities that support multiple MAHs at a single inspection of the service provider, which may result in a reduced inspection scope of MAH inspections, where a service provider had previously been evaluated as part of a stand-alone inspection (although an evaluation of interfaces and oversight by the MAH may still be required)"

Next Steps

 To test the feasibility of such a plan, MHRA reached out to 22 contract service providers last October, asking them to complete a survey and offering them the opportunity to volunteer for an inspection pilot.

MHRA says that 10 of the companies completed the survey, and seven asked to be part of the pilot. The agency says it will conduct the pilot with two of the interested companies sometime between Q2 and Q3 of fiscal year 2015/16.


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