National switches comprise the majority of OTC approvals in Europe, and will likely do so until the European Union opens restrictions on which drugs can use its nascent centralized switch process.
The European OTC industry has welcomed the advent of centralized switch, even if - with two products approved - it represents just "a crack in the door" in terms of European regulators' openness to OTC approvals, according to GlaxoSmithKline Consumer Healthcare Europe President Manfred Scheske (1 'The Tan Sheet' Feb 1, 2010).
But sponsors face some limits on what drugs are even eligible for the centralized procedure. Drugs that were originally approved via the prescription drug centralized process - such as alli (marketed by Roche as prescription Xenical ) - can automatically be considered. Others must apply via "non-automatic" entry, if they are not yet available OTC in any European market or only in "a few" countries.
Another eligible category is OTC drugs with an innovative form of administration or which represent a new combination.
A fourth category, under which no submissions have been received, is drugs for which different approval decisions have been taken by member states based on identical efficacy and safety. (Here it seems the idea is the European Medicines Agency acts as a final arbitrator.)
Several sessions during the Jan. 19-20 meeting of the Association of the European Self-Medication Industry in London were devoted to the relative competitiveness of Europe's national approval processes and its mutual recognition procedure and decentralized procedure. MRP and DCP both can be used to apply for approval across several European countries; DCP is used where a drug has not been previously approved in any member state, and MRP must be used if it has. In both processes a reference member state leads the procedure.
Martin Terberger, head of the pharmaceutical unit within the European Commission's Enterprise Directorate, acknowledged that "national processes should be quicker." They also should work better - in particular the process of automatic, mutual recognition process, he said.
Legislation is in place for this mutual recognition to occur, Terberger emphasized, and it offers an opportunity for countries to save work on the basis of trusting other states' decisions. The problem is each member state is authorized to decide whether and to what extent to exercise such trust. In practice, many don't, not least because of differing roles for pharmacists and divergent marketing regulations.
Procedures Can Take Years
But applying for approval under the decentralized or national processes can take years, according to Glenn Carpenter, senior director of regulatory affairs at Johnson & Johnson. He said securing a "time slot" in some countries can take up to two years; some countries say they can't take new applications until as far out as 2013, and other states can't provide any timeline at all (2 'The Tan Sheet' Nov. 24, 2008).
Carpenter presented data from an evidence-based survey involving eight multinationals, covering new OTC product applications from September 2008 to December 2009, and post-marketing applications from September-December 2009. Various measures were taken, including each member state's response times, receptiveness to applications, queue times, transparency and quality of feedback.
The results showed although it typically still takes an average of two to three years to secure a DCP timeslot (with Latvia, Portugal, Romania and Spain among the slowest), there have been improvements since 2008, notably in Italy, Sweden and the U.K. and particularly in Germany.
However, several states continue to refuse to act as reference member states - critical for pushing simultaneous or subsequent approvals across several countries. Reasons cited include a lack of resources and policies to accept only generic applications or products in specific disease areas.
When considering the entire range of approval routes, review times were similarly varied, but almost always were slower for national than for EU procedures.
OTC Drug Reviews Should be Quicker
OTC drug reviews in theory should be simpler and quicker than prescription drug reviews, given that they involve established medicines and known regimens. Smaller clinical and pre-clinical data packages also should allow for shorter review times. Yet, none of this is the case.
Part of the issue, Scheske pointed out in his talk at the AESGP meeting, is a lack of trust among regulators and doctors of OTC drugs and patients' ability to use them safely. There is also less up-front discussion with agencies in OTC applications than in new prescription drug applications, and thus, suggests Carpenter, there are fewer opportunities to secure those regulators' "buy-in."
So what can be done? The industry can and does publish its estimated drug submission forecasts to help agencies plan their workload. It can also make better use of the centralized procedure - but only if this becomes more accessible.
[Editor's note: Read more about this topic in 3 'The Tan Sheet,' your source for nonprescription pharmaceutical and nutritional industry news. For more information call 1-800-332-2181.]
- Melanie Senior (4 m.senior@elsevier.com)
