Drug Discovery
Behind every new medicine, there is a story......watch video
Pre Clinical Development
This stage of development is also called preclinical studies and nonclinical studies which begins before clinical trials can begin, and during which important feasibility, iterative testing and drug safety data are collected in the laboratory.
Clinical Trials
Clinical trials are experiments or observations done in clinical research. Such prospective biomedical or behavioural research studies on human participants are designed to answer specific questions about biomedical or behavioural interventions, including new treatments and known interventions that warrant further study and comparison. Clinical trials generate data on safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial – their approval does not mean that the therapy is 'safe' or effective, only that the trial may be conducted.
In a clinical trial, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or changes to participants' behaviour, such as diet.
Licensing
After successful clinical trials, a license will be granted before it can be made available for wider use.
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Licenses are only granted if strict safety and quality standards are met. For example, in the UK, licences are granted by the Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA), while in the USA, licenses are granted by the Food and Drug Administration (FDA).
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Licenses confirm the health condition the medicine should be used for and the recommended dosage.
This can be found in the information leaflet that comes with the medicine. The dosage instructions are usually on the label of the medicine packet.
Post Marketing Surveillance
Medicines continue to be carefully regulated after they've been licensed. This involves checking for problems and previously unknown side effects.
The monitoring of the safety of medicines or medical devices after it has been licenced is a critical part of the drug lifecycle and is also known as pharmacovigilance. Since drugs and medical devices are approved on the basis of clinical trials, which involve relatively small numbers of people who have been selected for this purpose – meaning that they normally do not have other medical conditions which may exist in the general population – post marketing surveillance can further refine, or confirm or deny, the safety of a drug or device after it is used in the general population by large numbers of people who have a wide variety of medical conditions.
Post marketing surveillance uses a number of approaches to monitor drug and device safety, including spontaneous reporting databases, prescription event monitoring, electronic health records, patient registries and record linkage between health databases.
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In rare cases, medicines may be withdrawn if there are serious safety concerns or the risks of the medicines outweigh the benefits.
