In March 2014 EMA launched a pilot project to explore the adaptive pathways approach, a scientific concept of medicines development and data generation intended for medicines that address patients’ unmet medical needs.

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(2016/2057(INI) Committee on the Environment, Public Health and Food Safety
Rapporteur: Soledad Cabezón Ruiz

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United Nations Secretary-General’s High-Level Panel on Access to Medicines calls for New Deal to close the Health Innovation and Access Gap

Whether it’s the rising price of the EpiPen, or new outbreaks of diseases, like Ebola, Zika and yellow fever, the rising costs of health technologies and the lack of new tools to tackle health problems, like antimicrobial resistance, is a problem in rich and poor countries alike.

According to a High-Level Panel convened to advise the UN Secretary-General on improving access to medicines, the world must take bold new approaches to both health technology innovation and ensuring access so that all people can benefit from the medical advances that have dramatically improved the lives of millions around the world in the last century.

Factsheet“2015 marks the 50th anniversary of the adoption of the first law on the authorisation of pharmaceuticals at EU level, which set the basis for some of the key principles that are still valid today.

Much of the impetus behind the adoption of the first law on pharmaceuticals at EU level stemmed from the determination to prevent a recurrence of the thalidomide disaster of the late 1950s early 1960s, when thousands of babies were born with limb deformities as a result of their mothers taking thalidomide as a sedative during pregnancy. This experience, which shook public health authorities and the general public, made it clear that to safeguard public health, no medicinal product must ever again be marketed without prior authorisation. Over the past 50 years a large body of legislation has been developed around this principle, with the progressive harmonisation of requirements for the granting of marketing authorisations and post-marketing monitoring implemented across the entire EU.

To mark the 50th anniversary of the adoption of the first EU pharmaceutical law the European Commission is organising a one-day conference that will take place in Brussels on 28 September 2015. The conference will review past achievements while focusing on the present and future role of EU pharmaceutical legislation in protecting the health of citizens in the EU and in the world, and in promoting advances in science, innovation and public health. Despite the many achievements there are still many challenges ahead. Different stakeholders see these challenges but each from different perspectives. The conference wants to bring to surface these different perspectives in an open and stimulating exchange with representatives from national governments, European institutions, national competent authorities, industry, healthcare professionals, academia and patient groups, with the objective of working towards a shared vision for the future.”

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by the PHARMACEUTICAL COMMITTEE of the EU-Commission (Health systems and products- Medicinal products – authorizations, European Medicines Agency) in relation to the Matrix-Report of 2012, referring to the Herbal aspect.

By Nora Laubstein (inspired by Dr. Mathias Schmidt and Dr. Hubert Schwabl)

The summary of comments about the Matrix report gives a fairly good overview about the regulatory difficulties of herbal medicinal products. But in the report a rather neutral position prevails.

An example - Looking back in German Herbal Medicines history:

Practically all of the registrations mentioned in the report for Germany are NOT new products or switches from food supplement to drug status; they are generally products that existed for many years as authorized herbal medicinal products.