◆ EMA to relocate to Amsterdam, the Netherlands (20-Nov-17 EMA)
The European Medicines Agency (EMA) will relocate to Amsterdam in the Netherlands. This decision was taken today by the EU 27 Member States in the margins of the General Affairs Council (Art. 50). The Agency now has just over 16 months to prepare for the move and take up its operations in Amsterdam on 30 March 2019 at the latest.
“We welcome today’s decision on the new location of EMA. Now that we finally know where our journey is taking us, we can take concrete actions for a successful move,” said EMA Executive Director Guido Rasi.
“Amsterdam ticks many of our boxes,” he continued. “It offers excellent connectivity and a building that can be shaped according to our needs. I am very grateful that the Member States took into account our requirements for business continuity and gave priority to the protection of public and animal health.
“Our internal surveys have shown that a large majority of EMA staff would be willing to move with the Agency to Amsterdam. However even in this case, our activities will be impacted and we need to plan for this now to avoid the creation of gaps in knowledge and expertise.”
EMA has to relocate due to the United Kingdom’s decision to withdraw from the EU. Amsterdam was one of 19 offers to host EMA submitted by the Member States at the end of July 2017. Today’s decision on EMA’s new location follows an assessment of the bids by the European Commission and EMA.
Notes
◆ GMP for ATMP – European Commission adopts new Guideline (29-Nov-17 ECA)
Relating to the increasing importance of advanced therapy medicinal products (ATMP) the European Commission and the EMA published a joint document in 2007 with a proposal for a community regulatory framework on ATMP. With the additional comments of DG enterprise and the industry they issued an implementation plan for the ATMP regulation (Regulation (EC) No 1394/2007) with a date for application on 30 December 2008.
In this time, the most ATMPs were in a phase of development and questions about scientific advice, registration and following marketing authorisation were more of interest than GMP issues. But with the increasing number of ATMPs and their development into phases with more GMP relevance, a more detailed guidance on Good Manufacturing Practice for Advanced Therapy Medicinal Products pursuant to Article 5 of Regulation 1394/2007 became essential. Therefore, a first consultation on the development of such a GMP for ATMP guideline was started in July 2015.
End of 2015 the submitted comments to the “Targeted stakeholder consultation on the development of Guidelines on Good Manufacturing Practice for Advanced Therapy Medicinal Products pursuant to Article 5 of Regulation 1394/2007” were summarized and published together with the responses on the European Commission’s website. The majority of the 48 contributions received supported the approach in the consultation document. Important was that a significant number of responses also objected to the principle that the Guideline would not apply to the hospital exemption and/or requested clarification of the scope of the Guidelines and links with general GMP rules. It was shown that for special GMP requirements, e.g. risk based approaches or necessary cleanroom classes, additional regulatory clarification and guidance is needed.
Out of the experiences and collected comments, a Draft Guideline on Good Manufacturing Practice for Advanced Therapy Medicinal Products was developed and is now open for a stakeholder consultation until 26 September 2016. The commission published the following objective of the consultation:
“Article 5 of Regulation 1394/2007 of the European Parliament and of the Council on advanced therapy medicinal products and amending Directive 2001/83/EC requires the Commission to draw up guidelines on good manufacturing practice specific to advanced therapy medicinal products.
A consultation on this topic was launched in 2015. On the basis of the comments received during the consultation, as well as input from consultation with the European Medicines Agency and competent authorities in the Member States, the Commission services have developed draft Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products. With this consultation, the Directorate General for Health and Food Safety wants to give an additional opportunity for concerned stakeholders to express their views on the GMP requirements that should apply to ATMPs.
The comments received will be taken into account by the European Commission to finalise the Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products.”
Further details can be found at the European Commission’s website on Advanced therapies – Major developments as well as the Consultation Document on Good Manufacturing Practice for Advanced Therapy Medicinal Products.
◆ WHO publishes Guideline on Worker Safety relating to Nanomaterials (31-Jan-18 ECA)
Relating to the fact that the importance of nanomaterials increases constantly – in pharmaceutical use as well as in other fields of research and industrial manufacturing – the WHO published a guideline document entitled “WHO guidelines on protecting workers from potential risks of manufactured nanomaterials (MNM)” end of 2017. This document pays attention to the small particle size of such materials which offers unique possibilities to develop better paints, better drugs and faster electronics. However, at the same time it bears new hazards for humans and the environment. Therefore, new risk assessments, new test methods and new regulatory standards are needed.
Currently, the knowledge and data base about human exposure pathways, impact of the human body and metabolism and possible biological effects is lacking or only fragmentary for many substances. And there are no long term side effects known either. But this can be reasoned by the short history of such products. Therefore the WHO states: “Health recommendations must, therefore, be based on extrapolation of the evidence from in vitro, animal or other studies from fields that involve exposure to nanoscale particles, such as air pollution, to the possible effects in humans. Workers in all countries will be at the front line of exposure to these materials, placing them at increased risk for potential adverse health effects.”
The new WHO document should now support responsible professionals in the field of occupational health and safety with recommendations on staff safety and protection from possible hazards as well as to guide additional workers and employers.
The WHO defined the following topics as important issues and questions:
Risks of MNMs
Which specific MNMs and groups of MNMs are most relevant with respect to reducing risks for workers and which should these guidelines now focus on, taking into account toxicological considerations and quantities produced and used.
Specific hazard classes
Which hazard class should be assigned to specific MNMs or groups of MNMs and how?
Forms and routes of exposure
For the specific MNMs and groups of MNMs identified, what are the forms and routes of
exposure that are of concern for worker protection?
Typical exposure situations
What are the typical exposure situations and industrial processes of concern for relevant specific MNMs or groups of MNMs?
Exposure measurement and assessment
How will exposure be assessed, and are there alternatives to current exposure assessment techniques for MNMs that should be recommended in LMI countries?
Occupational exposure limit (OEL) values
Which OEL or reference value should be used for specific MNMs or groups of MNMs?
Control banding
Can control banding be useful to ensure adequate controls for safe handling of MNMs?
Specific risk mitigation techniques
What risk mitigation techniques should be used for specific MNMs, or groups of MNMs in specific exposure situations, and what are the criteria for evaluating the effectiveness of controls?
Training for workers to prevent risks from exposure
What training should be provided to workers who are at risk from exposure to the specific MNMs or groups of MNMs?
Health surveillance to detect and prevent risks from exposure
What health surveillance approaches, if any, should be implemented for workers at risk from exposure to specific MNMs or groups of MNMs?
Involvement of workers and their representatives
How will workers and their representatives participate in the workplace risk assessment and management of handling MNMs?
For more information please read the complete “WHO guidelines on protecting workers from potential risks of manufactured nanomaterials”.
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