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Pharmacovigilance Accreditation Scheme?
Just received the latest email from the MHRA outlining the ‘MHRA Phase I Accreditation Scheme Requirements’, which focuses on units conducting Phase I clinical trials in the UK. The scheme is voluntary and has been running since April 2008. To apply for accreditation contract research organisations (CROs) can make an application to the MHRA and following the completion of a successful GCP inspection are recommended for accreditation.
The certificate is valid for 2 years, and a re-inspection is performed prior to this 2 year expiry to maintain accreditation and secure a renewal. Should any significant changes within these organisations take place within the 2-year certification period, the MHRA must be notified. The MHRA conducts a risk assessment of the changes reported and makes a decision on whether a re-inspection is required to maintain accreditation.
Obviously, fees apply and are consistent with current inspection-fee rates. There is an initial set-up fee, which I presume occurs on submission of an application, the inspection fees and a small fee for issue of the certificate. Having recently gone through the ISO9001 accreditation process, the concept does smack of similarity here. No prizes for the MHRA for ingenuity, but a great concept to introduce into the medical device and pharmaceutical industries, nonetheless.
I believe this is something that would be of value to the pharmaceutical industry. So, why not implement this for pharmacovigilance outsourcing partners. Using the above accreditation structure the role out of this 'niche' certification process should be simple and easily achievable and could extend to including key interfaces with pharmacovigilance such as medical information and quite possibly regulatory affairs.
It makes sense for the MHRA (or other local regulatory authorities) to point SME pharma companies considering an pharmacovigilance outsourcing partner to a list of ‘pharmacovigilance accredited’ bodies who authorities are confident have the infrastructure in place to support EU legislative requirements.
The implications of selecting the wrong provider can be far reaching for pharma companies, and with small pharma they may be detrimental to the continuity of the product and possibly the business itself. Changing your pharmacovigilance provider is considered a major safety variation by regulators, which makes this change all the more costly for small pharma.
The EMA recently issued changes to pharmacovigilance inspection fees making a point that outsourcing providers may be inspected as stand-alone units, thus reducing the need to perform repeat GVP inspections at the same facility for providers with multiple clients, saving on inspection fees and reducing the manpower required to conduct these inspections.
Surely, this type of 'niche' accreditation could have far reaching consequences for the industry, reducing the number of pharmacovigilance inspections required and enabling authorities to focus on areas that are genuinely high-risk. If quality patient care and patient safety is the primary end-goal of pharmacovigilance surely an accreditation process would go a long way to supporting these important objectives.
I really hope this wish comes true. Red Line Pharmacovigilance would be one of the first to apply.
Professional enquiry handling to support the safe and effective use of your products.
Ease the regulatory burden and keep compliant with current pharmacovigilance legislation.
Product safety through surveillance of published articles and case reports.
Confident staff to support the pharmacovigilance process.
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