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Medicines

There are many types of medicines including New Chemical Entities (NCEs), and generics. At every stage of a product lifestyle whether an established brand or new product, regulatory support is key to allow successful development and future sales. 

The very start of a product life cycle in the development laboratory is followed by scale up and formulation development. Non-clinical toxicology and pharmacology studies are carried out, followed by clinical trials in humans to provide safety and efficacy data. 

There is a lot of regulatory work required in order to plan and carry out the relevant processes in order to produce the data required to achieve the grant of a Marketing Authorisation by a Health Authority. All data to prove safety, quality and efficacy is required. The data to be generated requires initial assessment for compliance with the current regulatory legislation and guidelines in force. The data then requires generation, and will then need to be assembled into a submission ready format. Clinical trials must be only carried out after approval from a Health Authority.

Once a medicine has a regulatory approval and a Marketing Authorisation is granted, then maintenance activities commence. Any significant change needs to be submitted to the Health Authority for assessment and approval. These can include a range of manufacturing and quality control changes such as updates to a finished product specification, a new source of the drug substance, changes in names of companies used in the manufacturing process or changes in the manufacturing sites used. Variations also may be made to clinical aspects such as additional indications, or updates to the approved Summary of Product Characteristics (SmPC). Most packaging changes also require notification to the Health Authority. 

Pharmacovigilance of a product must be carried out and Periodic Safety Report (PSURs) prepared and supplied to the Health Authority on a regular basis.