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Pharmacovigilance
Pharmacovigilance - new medicines and vaccines

Pharmacovigilance - new medicines and vaccines

Report suspected side effects to medicines, vaccines, e-cigarettes, medical device incidents, defective or falsified (fake) products to the Medicines and Healthcare products Regulatory Agency.

COVID-19

The COVID-19 pandemic brought unprecedented challenges for us all globally. A time in which we have all had to learn to quickly adopt new and different ways of learning and connecting with one another, this also holds true for the development of the COVID-19 vaccines.

The emergency approval of the vaccine during the COVID-19 pandemic ensured that it was made available to patients quickly without compromising the safety of patients, more information on what role pharmaceutical companies played in response to COVID-19.

Early Access to Medicines Scheme (EAMS) and the Innovative Licensing and Access Pathway (ILAP)

Other such pathways which enable patient access to medicines earlier are through programs such as EAMS and ILAP, these programs provide crucial and lifesaving medicines to patients via an accelerated approval process before the medicine receives marketing authorization.

Where the EAMS scheme offers patients with access to medicines earlier than the marketing approval of the medicine, the ILAP program provides an accelerated approval pathway for medicines aiming to improve patient access.

EAMS

EAMS provides patients with serious health conditions the opportunity to receive medicines which have not yet received marketing authorization. The EAMS programs are generally granted a 1 year approval after which MAH’s (marketing authorisation holders) can apply for re-approval should the need arise. Information is available on all approved EAMS programs on the Medicines and Healthcare products Regulatory Agency (MHRA) website, which lists a public assessment reports under each EAMS program which provides patients with background information around the use of the drug more information, and also provides prescribing health care professionals (HCPs) the in-depth information that they need to register their patient on the scheme

Read the public assessment reports

The MHRA website provides a step-by-step guide on how MAH’s can apply for the EAMS programs. further information on this can be obtained by clicking on the following link https://www.gov.uk/guidance/apply-for-the-early-access-to-medicines-scheme-eams.

Download a larger PDF version of this overview at the link below.

Early access to medicines scheme (EAMS): how the scheme works

Innovative Licensing and Access Pathway (ILAP)

The Innovative Licensing and Access Pathway (ILAP) runs alongside EAMS, it provides access to a broader scope of medicines and is inclusive of all innovative products. The ILAP provides the opportunity for input from a range of stakeholders such as NICE (National Institute for Health and Care Excellence), SMC (Scottish Medicines Consortium), and the all Wales Therapeutics and Toxicology Centre, as well as the NHS, and HRA (Health Research Authority), more details around ILAP are available by clicking on the following link https://www.gov.uk/guidance/innovative-licensing-and-access-pathway.