The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published guidance for companies submitting a Manufacturing Authorisation application or variation on...06 January 2017
MHRA ANNOUNCES EARLY ACCESS TO MEDICINES SCHEME
The EAMS is a voluntary scheme which runs in parallel to the normal marketing authorization procedure for medicinal products in the UK. Similarly to the US FDA scheme on Breakthrough Products Designation, the EAMS is intended to assist patients with life threatening or seriously debilitating medical conditions who have no suitable alternative treatments.
The application procedure for the EAMS occurs in two steps:
- The preliminary step involves the assessment of the clinical data related to the medicinal product to determine whether the medicinal product should be designated as a Promising and Innovative Medicine ("PIM"). This designation would provide an early indication that the medicinal product could be an eligible candidate for the EAMS scheme.
- The second step is the issuance of a scientific opinion on the application for the EAMS by the MHRA. The opinion is based on the benefit/risk profile of the medicinal product. Prior to submitting an application for a scientific opinion in accordance with this second step, the applicant company will be required to attend a pre-submission meeting with the MHRA. This meeting is intended to ensure that the medicinal product is suitable for the EAMS and to discuss the format of the data to be submitted in support of the company's application.
An application for a scientific opinion by the MHRA concerning the EAMS must be submitted by specific dates. These dates are provided on the website of the MHRA. The first deadline for submission of an application for a scientific opinion is 5 May 2014.
Positive scientific opinions for inclusion in the EAMS will be made available on the MHRA’s website through a Public Assessment Report. This Public Assessment Report will also contain information on the method, posology and administration of the medicinal product, summaries of key clinical studies, the basis for the positive opinion and information concerning any further measures that have been established to monitor and manage any risks associated with the medicinal product.
The scientific opinion issued by the MHRA will be valid for one year and may be subject to yearly renewals thereafter. Once the MHRA issues a positive scientific opinion, the applicant company would be required to regularly update the information provided in the original application by submitting a periodic update report to the MHRA for consideration. Applicant companies are also required to use the template periodic update report provided by the MHRA when requesting renewals of a scientific opinion.
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