Whitepaper: Emerging trends in regulatory expectations

Regulatory expectations nowadays focus on harmonisation of global regulations. This whitepaper by PQE looks at current and emerging trends in regulatory expectations.

The ultimate target in the pharmaceutical and medical device industries is to ensure patient safety within the entire product life cycle, from R&D to distribution.

Quality of medical products (both drugs and devices) becomes a social and ethical responsibility as products are developed, produced and distributed for preventing, treating and reducing discomforts of diseases.

The final user/patient trusts the medical products efficacy and simply relies on them. A continuous commitment from manufacturing companies and from those involved in the product life-cycle is in need to continue gaining patient confidence.

Together with the principles and guidelines that the regulatory authorities are laying down for the industry (ie, regulatory requirements) we can say that quality of medicines is not “only” mandatory by law, but also a social and ethical responsibility.