Pink Sheet: 世界の薬事規制と承認審査に関するニュース
By John Davis 31 Mar 2020
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the...
A position paper from the UK government has laid out some ideas for ensuring a smooth transition to a post-Brexit world in the area of regulation, with a focus on issues such as marketing authorization validity, continued regulatory oversight, inspections, and adverse drug reaction reporting.
The UK government has finally laid out its thoughts on some of the key issues surrounding the regulatory framework for pharmaceuticals after Brexit, including the need to ensure the ongoing validity of EU marketing authorizations, registrations and certificates, and the importance of unbroken oversight of regulatory activities and requirements.
In its latest Brexit position paper, entitled “Continuity in the availability of goods for the EU and the UK”, the government says that any marketing authorizations or other approvals issued before Brexit “should continue to be recognised as valid by both markets after the UK’s withdrawal.” It adds that there should be no requirement to re-inspect manufacturing facilities approved before the UK’s departure from the EU.
It is the government’s desire, it explains, to maintain the “deeply integrated trade and economic relationship” between the UK and the EU after Brexit, and to provide legal certainty and avoid disruption for business and consumers with respect to the continued availability of goods in the EU and the UK. “In doing this, it makes sense to recognise our common regulatory systems and the UK’s ambition for cooperation in the future.”
In other words, the government wants things to continue pretty much as they are despite the UK’s decision to quit the EU. Given the highly regulated nature of the life science sector, this should be music to the ears of the industry and regulators alike.
The proposals are just the UK’s opening gambit, and they may well be perceived by the EU as yet another example of the UK wanting to “have its cake and eat it.” And with the EU still intent on tackling the financial settlement, the Irish border and citizens’ rights before moving on to the future UK-EU relationship, it could be some time before the ideas in the paper even reach the negotiating table.
The Association of the British Pharmaceutical Industry and the UK BioIndustry Association welcomed the “pragmatic approach” laid out in the paper, saying it provided “a constructive starting point for arrangements that aim to minimise disruption to vital safety and monitoring processes for medicines and avoid any negative impact to medicines supply.” They added, “we urge the EU and UK to discuss this issue with Europe’s patients front of mind.”
Industry was also pleased that the paper seemed to acknowledge its contribution into the Brexit process. During a BIA Brexit webinar on Aug. 22, Steve Bates, CEO of the BIA, said: “I am delighted to say that it has been informed by some of the expert work that we and the ABPI have been able to input into this, so I think is good to see reflected back to us in this paper the importance of some of the issues that we stressed in the work on trade that we have been doing.”
“The paper has been informed by some of the expert work that we and the ABPI have been able to input into this” – BIA CEO Steve Bates
According to the position paper, a “key element” of delivering a “smooth, orderly exit” from the EU for business and consumers is ensuring that products can be lawfully marketed in the UK and the EU.
This includes goods which are placed on the market before the date of withdrawal but cross the UK/EU border after exit. “The UK’s position is that these should be discussed and resolved in a way that supports the move to a future relationship.”
A key compliance activity, the paper says, is that many products must undergo third-party assessment or submit a registration before being placed on the market to ensure the product meets the requirements in relevant product legislation. “These assessments can be valid for a full product life-cycle, or in some cases be time limited or required for a representative sample of goods,” it observes.
The government says it wants to ensure that “any approvals, registrations, certificates and authorisations issued by a third party (whether a private entity or a public agency) prior to exit should continue to be recognised as valid by both markets after the UK’s withdrawal.”
These assessments will have been conducted and the data will have been provided in accordance with legislative requirements “by a body recognised as competent,” so it would avoid disruption and provide legal certainty if the results of these activities were recognised in both markets. “These approvals should be valid for the intended time period or product life-cycle as when they were granted to avoid the need for retesting of products.”
Bates said in the webinar that the principles in the paper with regard to the “grandfathering” of goods were important. “I believe this will refer to centrally authorized products, no changes in labelling, MAH (marketing authorization holder) location, master files etc, and I hope this is about compliance activities prior to Brexit being respected and not duplicated,” he remarked.
Oversight of regulatory compliance before and after the UK’s withdrawal is a key issue. The paper observes that businesses undertake “complex, lengthy and often costly procedures” to make sure that goods and business practices are compliant with EU legislation. This could include “undergoing an inspection by an EU-recognised body to ensure production is in accordance with Good Manufacturing Practice or collecting and submitting data on the hazards and risks of a chemical substance.”
The withdrawal agreement “should recognise the validity of compliance activity where it has taken place prior to exit” – UK government position paper
The withdrawal agreement “should recognise the validity of this compliance activity where it has taken place prior to exit,” and this should be “recognised for the full time period or type of products intended when the compliance activity was undertaken.”
Any further compliance activity required after Brexit as a result of the prior compliance activity should be conducted as originally intended. “This would avoid business and authorities in both the EU and the UK needing to undertake significant duplicative compliance activity after exit, for example to re-inspect approved manufacturing plants or collect and submit data again.”
One example is the ongoing role conferred on authorities or businesses, for example the role of a Qualified Person in testing and batch release of medicines. Here, the government says it “wants to avoid unnecessary disruptive transfer of activities between the EU and the UK, and these ongoing activities being duplicated for both markets, particularly where the UK’s aim is for this activity to be recognised as part of a future relationship.”
“Therefore, the UK proposes that for any compliance activity recognised through the withdrawal agreement, the authority and business should be able to continue to carry out ongoing functions for relevant products or types of products for both UK and EU markets and this activity can take place in their location as at the date of withdrawal.”
Where there are ongoing obligations for the assessment bodies after a product has been assessed, “the UK proposes that bodies should continue to fulfil any ongoing obligations for the product life-time.”
Once a product is placed on the UK and the EU markets, it is essential that both parties can trace products through the supply chain and market surveillance authorities can ensure action is taken with respect to non-compliant goods. Failure to support oversight by market surveillance and enforcement authorities could cause significant disruption and uncertainty for consumers of goods.
This encompasses a broad range of activity, for example requirements on market authorization holders to report adverse reactions to medicines and “the ability of market surveillance or enforcement authorities to exchange information about unsafe products.”
Whether these key principles provide legal certainty while avoiding disruption is up for debate, given that this is a paper for discussion by the negotiators, and is “only one side of the debate,” Bates observed. “But it is positive that it reflects much of the input of our expert groups. So it is good that we are being listened to as an industry, although we have further to go,” he concluded.
The Brexit negotiations are due to restart on Aug. 28 after a short summer break.
Pink Sheet: 世界の薬事規制と承認審査に関するニュース
By Ian Schofield 31 Mar 2020
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