Last week’s round-up, 03-07 February 2020

By Stephanie Allampalli, Tessa Fiorini-Cohen and Marthese Mifsud

The Essential List of Regulatory Authorities in Europe

07 February 2020

RAPS has published a useful list of websites of drug and medical device regulatory authorities in Europe.

The list includes links to websites of national regulators found in the European Union and European Free Trade Association (European Economic Area), as well as other European countries. For more information please see the following link: http://bit.ly/RealGenerics-31wwAyM

EU flags are up in EMA’s new building in Amsterdam

06 February 2020

EU flags have been raised in the EMA’s new and final home in Amsterdam.

Guido Rasi, EMA’s Executive Director, stated that the flag-raising ceremony closes the agency’s relocation chapter and that the EMA can now “finally refocus fully on our public-health mission”. The agency moved into its final building in the Zuidas area of Amsterdam at the beginning of this year: http://bit.ly/RealGenerics-3bfaq8T

UK withdrawal from the EU on 31 January 2020

05 February 2020

Following the withdrawal of the United Kingdom from the European Union on 31st January 2020, a transition period has begun and is due to end on the 31st December 2020.

Until the end of the transition period, pharmaceutical companies may continue to operate in the UK since EU pharmaceutical law will continue to be applicable to the UK.

During this time, pharmaceutical companies should make the necessary changes in order to ensure that their authorised medicines comply with EU law and may remain on the EU market after the end of 2020.

However, as of the 1st February 2020 the UK will not be allowed to participate in EU institutions. Therefore, UK representatives and nominees may no longer participate in meetings of the EMA’s scientific committees, working parties or Management Board.

http://bit.ly/RealGenerics-36XgEXp

FDA calls meeting on standardization of talc testing methods

04 February 2020

Asbestos in talc is the focus of a public meeting being held today by the FDA.

One of the meeting’s main purposes is to discuss preliminary recommendations for talc testing protocols, published last month by the Interagency Working Group on Asbestos in Consumer Products (IWGACP). Asbestos is a potential contaminant within talc as raw material talc is obtained from mines that may also contain asbestos and related minerals. Current testing guidelines have been deemed inadequate and outdated, and the meeting will cover methodologies, terminology and criteria that can be applied to characterize and measure asbestos: http://bit.ly/RealGenerics-2OqtGXa

EMA Celebrates 25th Anniversary

03 February 2020

The European Medicines Agency (EMA) has just celebrated its 25th anniversary since its foundation in 1995.

Through its collaboration with the European Commission and regulators in the EEA, the EMA has created a system for evaluation and supervision of medicines in the EU, thus, ensuring high standards for human and animal health.

During the past 25 years, the EMA has helped develop specialized medicines for rare diseases, herbal medicines, paediatric medicines and advanced-therapy medicines. The EMA has also approved the first biosimilars, the first stem-cell medicines, and the first gene therapy in the EU. In 2016 the EMA launched its  PRIority Medicines Scheme and the following year it entered into mutual recognition agreements with the US to streamline the facility inspection system.

http://bit.ly/RealGenerics-2u62PJ8

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