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A robust ‘Validation of an Analytical Method’ for regulatory submission should provide a level of detail to satisfy the health authority that the method is fit for purpose, thereby reducing requests for further information, whilst minimising superfluous information.

Launched at the start of the year, the UK Medicines and Healthcare products Regulatory Agency's (MHRA) new “International Recognition Procedure” (IRP) has approved its first MAA for Amgen’s bone cancer drug Xgeva (denosumab). The IRP is one of several efforts by the regulator to streamline the approval of new medicines and expedite access to new drugs for patients.

Replacing the European Commission’s Decision Reliance Procedure (ECDRP) and allowing the MHRA to 'recognise' the expertise of specific Reference Regulators (RR) in other countries (Australia, Canada, Switzerland, Singapore, Japan, USA and European Union/EEA) when evaluating applications for medicines already authorized elsewhere, it can offer certain companies an alternate regulatory pathway to UK Marketing Authorisation (MA). This Need to Know provides some key information about this procedure and evaluates its benefits to the Industry.

A robust analytical method for regulatory submission should aim to provide the detail required to satisfy the health authority (HA) thereby reducing requests for further information yet minimise superfluous information, which may later incur further regulatory submissions for change.

Radiopharmaceuticals are a unique class of drugs that are used in nuclear medicine for diagnostic and therapeutic purposes. These drugs contain a radioactive atom that is used to produce images of the body or to treat disease. This article explores the basics of the regulatory processes for radiopharmaceuticals in the United States (FDA) and the EU (EMA) as well as the challenges faced to ensure the safety, efficacy, and quality of these drugs.

Medicine manufacturers may spend billions in research and development to attain the holy grail of the Industry: an authorisation allowing it to place a medicinal product on the market. Only after this may they start to recoup some of this investment. That is not the end of the story of course, since without a robust system of change control, over time this coveted registration can drift away from the actual product that is being manufactured, which can pose a significant risk to patients. This is far from uncommon and ultimately costs the life sciences industry millions through the necessary allocation of its stretched resources to Chemistry, Manufacturing and Control (CMC) initiatives, not to mention the reputational damage caused with regulatory bodies and the public, when products may be temporarily or permanently removed from the supply chain. By using proven methodologies and tools, and encouraging a robust change management ethos, the burden of CMC conformance on the industry can be reduced from having to undertake repetitive rounds of these resource-intensive activities.

This insight explores unlicensed medicinal products and the importation pathways for making these products available to patients in the United Kingdom.

The UK "specials" regime is quite well known for unlicensed medicines in the UK, which are authorised in other markets. The other routes available and other types of unlicensed medicines are summarised in this article and discussed in detail in the accompanying paper.