Regulatory Issues Main Challenge Facing Life Sciences Companies

Regulatory and Patient Safety Issues constitute the greatest future challenges for the life sciences industry

Pharmaceutical and medical device companies operate in an extremely regulated environment, where Governments are investing significant resources to ensure that the industry remains compliant with the overarching objective of securing patient safety. The results demonstrate that industry is concerned about issues like counterfeit products and supply chain security.

When asked about the main challenges facing the industry today, manufacturers identified regulatory issues (64.7%) as being the most important, followed by patient safety (53.3%) and supply chain issues (47.1%).

Service Providers identified supply chain issues (64.3%) as their greatest challenge. Regulatory issues and market access issues were identified as being of equal importance (33%) in terms of the challenges that they presented.

What is the industry interested in?

The overall consensus was that customs and licensing issues and anti-counterfeiting are areas that are very relevant to both manufacturers and service providers.

The survey results show that service providers are more interested in supply chain related issues such as transport technologies, retail storage and transport control and reverse logistics.

Manufacturers are more interested in regulatory aspects such as regulatory and compliance issues, customs and licensing issues, packaging and marking and the different rules applied in different countries.

This might be a reflection of the difficulties faced by the two different industry sectors. Manufacturers have to deal with the Regulators at the early stage of the drug / medical device development process. This mirrors their major concerns for the next three years, i.e. patient safety and regulatory issues. There is clear evidence that governments worldwide are increasing their efforts at ensuring supply chain security to reduce the risk to the final end consumer, i.e. the patient. With the continued increase in prescribed and non-prescribed counterfeit medicines entering the legitimate supply chain, governments are developing new regulations and increasing levels of vigilance that they exert over the stakeholders in the life sciences industry to ensure that risk to the patient is minimised.

Service Providers are more interested in the distribution side. They are the entity thatis entrusted with delivering the final product to the end consumer. This explains the high interest in transport technologies. New track and trace technologies are constantly being developed and improved. With more pharma and medical device products requiring temperature controlled environments, service providers must be aware of the requirements of industry to ensure that they are capable of providing the services required.


Life Sciences Ireland is committed to continue developing its services to assist the life sciences industry in Ireland to maximise its export potential.

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