In December, Michael Rawlins was appointed head of the U.K.’s Medicines and Healthcare products Regulatory Agency. He recognizes the MHRA’s mutually beneficial relationship with European counterparts and is looking to safeguard synergies with other national regulatory bodies and NICE.
The recently appointed chairman of the MHRA, Michael Rawlins, holds the unique status of having headed up both the medicines agency and national health care technology assessment body, NICE. Rawlins spoke with “The Pink Sheet” about the MHRA’s new format and future priorities, its existing and potential synergies with NICE and the intricate role of the agency within the European setting and the EU’s network of national medicines agencies.
MHRA Chairman Michael Rawlins
The European Medicines Agency’s inaugural bilateral meeting with the Association of Clinical Research Organizations underscores ACRO’s commitment to advancing innovation and its presence in the EU clinical trials ecosystem.
The health technology assessment institute, NICE, said the price BioMarin was asking for Brineura was too high, even though its appraisal committee applied a cost-effectiveness threshold ten times higher than usual.
Vertex and Biogen are working with the Dutch government to ensure access for eligible patients.
The pharmaceutical industry is edging closer to EU-wide clarity on how the bloc’s data privacy rules can be applied consistently to clinical trials and pharmacovigilance activities.
While the government announces eight to 15% cuts to the four products, industry groups urges for its operational improvement without expansion.
Returning FDA biologics center director Vinay Prasad used the Papzimeous approval announcement to reinforce his flexibility on rare disease therapies after several complete response letters and his brief departure from the agency.
Enhancing the consistency and clarity of information requests and discipline review letters, and improving assessment milestone communications are key areas targeted by generic drug makers for user fee program negotiations.
