Tag Archives: Ema

EMA and The Netherlands Biopharm Opportunities

The European Medicines Agency (EMA) is relocating from London to Amsterdam.

According to EMA, the Seat Agreement allows EMA to function independently in the Netherlands. Similar agreements apply to other EU agencies located in the Netherlands.

On Friday, 13 April 2018, the Dutch Council of Ministers agreed to sign the document.

Amsterdam – EMA

Quantify research reported earlier this year that the shift of the EMA to Holland will be a welcome boon to that country, particularly due to some companies shuttering their Netherlands locations in favor of other European countries. The research report pointed to more than 1,500 job losses about eight years ago following Abbott and Merck Sharpe and Dohme closing facilities in that country. Between 2009 and 2014, Quantify said the Dutch market share in the European pharma industry plummeted from 3.3 percent in 2009 to 17 percent in 2014.

To help spur the resurgence of the Netherlands pharma industry, the Netherlands Foreign Investment Agency is hosting a landscape tour at the end of summer to showcase the country’s offerings. While the EMA is expected to become the core of the Netherlands biopharma industry, the NFIA said the country is home to facilities for more than 420 biopharmaceutical companies, such as AstraZenecaJanssen, MSD, Amgen and Teva, to name a few. The Netherlands Foreign Investment Agency pointed to the companies because they “rely on their Dutch operations for both R&D and distribution activities.”

But, it’s not just the large global pharma companies that have a home in Holland. The country is also home to a number of biopharmaceutical startups and scale-ups, like GalapagosGenmabPharming and uniQure.

Another company that will be relocating to the Netherlands is Gilead Sciences.  This new facility will be employing over 300 people. Other companies worth mentioning are GSK-Novartis, Merk and most well-known Clinical Research Organizations (CROs) have made the Netherlands their home.

For those interesting in working and living in Amsterdam, you should know that it is one of the countries with the highest taxes at a 52% income tax rate if you make over 55,000 euros per year (apparently they think this is good money). For a regular employee with benefits, your tax rate will be at a 42 %. Don’t expect to be making more than 55,000 euros a year unless you are a highly skilled employee or hold a managerial level position.

Tot Ziens!

Source:

Biospace

EMA

https://www.government.nl/latest/news/2018/04/23/the-european-medicines-agency-ema-and-the-netherlands-agree-on-seat-agreement

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ICH is coming to Town – European Medicines Agency (EMA)

The International Conference on Harmonization (ICH)  is involved in promoting public health, improve efficiency of new drug development and registration process among other objectives. In order to accomplish this, ICH has developed and implemented harmonized guidelines and standards, also known as ICH6.

ICH Steps

Over 50 guidelines on technical requirements on:
Quality, Safety and Efficacy
Efficacy – 14 topics/17 guidelines
Safety – 8 topics/16 guidelines
Quality – 9 topics/23 guidelines

  • Maintenance of ICH Controlled Terminology Lists
  • Medical dictionary for adverse event reporting and coding
    of clinical trial data (MedDRA)
  • Electronic Standards for the Transfer of Regulatory
    Information
  • Common Technical Document (CTD & eCTD)

The European Medicines Agency (EMA) is a decentralised body of the EU. EMA is responsible for centralised procedure and co-ordination of EU network + plays a role in stimulating innovation and research in the pharmaceutical sector.

EMA is not an FDA for Europe

EMA responsibility does not include:

  • Evaluation of all medicines in the EU
  • Research/development of medicines
  • Clinical trial approval
  • Medical devices
  • EU healthcare policies
EMA Regulatory Process

 

 

Conclusion: ICH-GCP guidelines brought forth public awareness that there was a need to control and regulate clinical trials dealing with drugs and human subjects.

ICH main goal is to provide a unified standard for the European Union (EU), Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.

Source:

Guidelines on good clinical practice (European Community and within the ICH regions)  – https://ec.europa.eu/

Presentation – ICH and EU regulatory – www.ema.europa.eu

 

Recommended Posts:

https://edcdeveloper.wordpress.com/2015/05/11/are-you-practicing-gcp/

https://edcdeveloper.wordpress.com/2011/11/17/21-cfr-part-11-cheat-sheet-for-the-edc-developer/

Fair Use Notice: Images/logos/graphics on this page contains some copyrighted material whose use has not been authorized by the copyright owners. We believe that this not-for-profit, educational, and/or criticism or commentary use on the Web constitutes a fair use of the copyrighted material (as provided for in section 107 of the US Copyright Law).