The government has announced a new initiative aimed at halving the time it takes to switch a prescription-only medicine (POM) to over-the-counter (OTC) status.
Chancellor of the Exchequer George Osborne announced the initiative last week in his Autumn Statement, and the Medicines and Healthcare products Regulatory Agency (MHRA) has now launched a new, streamlined procedure for switching, to take effect immediately.
The reform is underpinned by a new guideline on how to change the legal classification of a medicine in the UK which, says the MHRA, could cut the time from application to decision by three months or more.
To streamline and shorten the reclassification process, the new guidance will:
– minimise the need for formal engagement during the assessment process by increasing engagement with applicants before submission and encourage pre-application collaborative work with key stakeholders;
– reduce the types of applications which would require engagement with stakeholders during the application process;
– minimise the occasions on which expert advice would be sought; and
– make stakeholder engagement more focussed and time-limited.
Other improvements include a new presentational structure aimed at guiding applicants through the reclassification process, from product development within companies to submission, assessment, approval and risk management activities. The guidance includes a new section on benefit/risk assessment to help applicants evaluate a candidate product prior to submission, to provide a rationale for their justification that the balance of benefits and risks are in favour of the product as a non-prescription medicine.
The document also includes new appendices which present guidance on how to structure applications to be consistent with European Union (EU) guidelines, together with information on how to avoid common pitfalls plus frequently-asked questions and answers.
The Proprietary Association of Great Britain (PAGB), which represents the OTC industry, said it welcomed the new streamlined procedure. “The UK has led the world in switching medicines from prescription control, ensuring that the medicines available over the counter are as effective as those a doctor would prescribe for common ailments, prevention of certain illnesses and treatment of recurring conditions,” commented Helen Darracott, director of legal and regulatory affairs at the PAGB.
“The new process could cut the time for switch by three months or more and it introduces a new benefit/risk model to help assess whether a drug is a suitable candidate. This will give new impetus to this programme,” said Ms Darracott.
Jeremy Mean, group manager of vigilance and risk management of medicines at the MHRA, also noted that the UK “has long been recognised for its leadership in increasing access to medicines by making prescription medicines available over the counter where it is safe to do so.”
The new process and the guidance that underpins it “will speed and streamline the way medicines are made available safely, with benefits for the medicines users, the regulator and the industry,” he added.
The initiative has been developed by the Agency in collaboration with the pharmaceutical industry as part of the Better Regulation of Medicines Initiative (BROMI) and its response to the government’s Red Tape Challenge. Its introduction follows a consultation launched by the MHRA in July.
