The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological...20 January 2017
EUROPEAN MEDICINES AGENCY COMMENCES PATIENT CONSULTATIONS DURING THE BENEFIT/RISK ASSESSMENT OF MEDICINAL PRODUCTS
The introduction of the pilot project reflects the EMA's wider strategy to improve the involvement of patients in the conduct of the EMA's activities and initiatives. The work programme of the CHMP explicitly recommends the integration of patients’ views in the assessment of the benefit/risk profile of medicinal products.
As part of the pilot project, the rapporteurs and the EMA team leaders will decide on a case-by-case basis whether product-specific oral explanations would benefit from the input of certain patients during discussions on the benefit/risk profile of the medicinal product.
According to an EMA guidance document that outlines the main principles of the pilot project ("Guidance Document"), patient consultations in the context of these oral explanations will be considered only in the following cases:
- When the CHMP is likely to recommend the refusal of a marketing authorisation for a new medicinal product even though an unmet medical need remains.
- A significant impact on the patient population is expected due to the likelihood of a recommendation by the CHMP or the PRAC to withdraw, suspend or revoke a marketing authorisation, or restrict the authorised indication(s) of an authorised medicinal product.
Following an assessment of any potential conflicts of interest, patients will be selected to participate in the pilot project depending on their personal experience and knowledge of the particular disease/condition under evaluation. Carers of patients may also be selected based on the same criteria.
According to the Guidance Document, patients will be contacted through a list of eligible patient organisations or other European Union ("EU") or national organisations. Individuals who have expressed an interest in participation in the EMA's activities may also be contacted by the EMA.
The eligible patients will provide their views and may participate actively in the discussions, including the rapporteur's briefing meeting, the presentation by the applicant pharmaceutical company and the subsequent question and answer session. Furthermore, they may have the possibility to ask questions to the applicant company. Patients would not, however, be permitted to take part in any decision-making process concerning the benefit/risk profile of the medicinal product.
According to the EMA press release, the first medicinal project to be assessed as part of the pilot project contains the active substance afamelanotide which is intended to treat erythropoietic protoporphyria (EPP).
The proposed duration of the pilot project is expected to be one year. At the end of this period, the CHMP will review and evaluate the pilot project. As part of this review, the CHMP may consider a proposal to fully implement the project on a long term basis.
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
On 16 December 2016, the European Medicines Agency (“EMA”), along with the European Biopharmaceutical Enterprises (“EBE”) organised the fifth annual regulatory...03 January 2017