Without further work, the EU-wide joint clinical assessments introduced by the EU regulation on health technology assessments will fail to meet the needs of advanced therapies, warns the Alliance for Regenerative Medicine.

IMC, the R&D-based pharmaceutical industry association in Canada, says the guideline will “exacerbate an already unpredictable regulatory environment.”

Canada’s health technology appraisal body is seeking feedback on guidance on the use of real-world evidence in decision making.

ANVISA, Brazil’s medicines regulator, is asking for feedback on the regulatory pathway for biosimilars.

ANVISA, Brazil’s medicines regulator, is asking for feedback on the regulatory pathway for biosimilars.

Regulatory reliance will be vital in improving access to oncology medicines in low- and lower-middle income countries, delegates at a recent regulatory conference were told.