The pharmaceutical industry includes products borne out of drug discovery programmes, extensions to existing product lines, longstanding brand lines and generics, and prescription-only-medicines.
A major strain for the pharmaceutical industry is the development process for new drugs this is costly and can take over 10 years from the laboratory to Clinical Trials. Typically only 5 of 5,000 compounds that have been assessed at the Pre-clinical stage will reach human Clinical Trials. Of these 5, only 1 will be approved by the Regulatory Authorities.
Legislation and Regulatory bodies surrounding Pharmaceutical products
The driving principle behind all regulatory requirements is product Quality, Safety and Efficacy. Pharmaceutical regulatory legislation includes controls that govern all parts of the product development and registration processes including:
• Product manufacture, validation, testing and release
• Marketing Authorisation Application
• Product maintenance throughout its lifecycle
Pharmaceutical product manufacturers face a number of challenges, from Developing Analytical methods for high throughput screening of candidate compounds, to registering Investigational New Drug Applications, filing Marketing Authorisation Applications and ensuring cGMP compliance is maintained.
The governing bodies for the pharmaceutical industry include both national and regional organisations such as the Food and Drug Administration (FDA) in the US, the Medicine and Healthcare Product Regulatory Agency (MHRA) in the UK, and the European Medicines Agency (EMA). Interpreting the requirements of these boards of health, submitting relevant information and responding to any queries and Requests for Information (RFI) is essential to securing and maintaining authorisation to produce and supply pharmaceutical products and cGMP.
Key Trends in the pharmaceutical industry
Recent developments in the pharmaceutical industry include:
• Developing line extensions of products
• Maximising the duration of marketing authorisation exclusivity
• Acquiring and developing generic products at an earlier stage
• Outsourcing manufacturing and Licence Maintenance activities to reduce costs and overheads
These require due diligence activity prior to acquisition to ensure the regulatory standards are reflected in the value of product lines, and clear regulatory strategies are developed for compliance and conformance, stringent management of suppliers and departments to ensure safe effective medicines are produced.
How Woodley BioReg can help the pharmaceutical industry
Woodley BioReg can assist the pharmaceutical industry at all stages of product development, providing trusted and professional advice on Regulatory Affairs, Quality System development and Project management through our flexible resourcing support, which provides remote support or consultants at your site, on a long term or short term basis.
For more information on pharmaceutical consulting please contact us