Finding Harmony With ICH, Regulatory Authorities and Pharmacopoeias

While harmonization efforts and the leadership of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and World Health Organization (WHO) have proven helpful in minimizing the prior variance and complexity in the drug development pathway for GMP-regulated labs, their interactions with individual pharmacopoeial monographs, as well as regulatory agencies, could often use a bit more explanation.

ICH is driving harmonization to accelerate the drug approval process

ICH’s mission is to achieve greater harmonisation worldwide to ensure that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner. Harmonisation is achieved through the development of ICH Guidelines via a process of scientific consensus with regulatory and industry experts working side-by-side. Key to the success of this process is the commitment of the ICH regulators to implement the final guidelines.

Pharmacopoeias are providing monographs and reference standards to fulfil ICH guidelines requirements

In addition to the United States Pharmacopeia (USP), there are three other well-known pharmacopeias in the world, the European Pharmacopoeia (EP), the British Pharmacopoeia (BP), and the Japanese Pharmacopoeia (JP), all of which share the goal of publishing and producing quality standards for medicines. Other countries have smaller national pharmacopoeias that work collaboratively in order to achieve harmonization and simplify the complexities of guaranteeing the quality of a drug product moving to the commercial manufacturing phase.

Regulatory authorities are ensuring the safety, efficacy and quality of medicines

The regulatory authority’s mission is simply to safeguard the health of the public by evaluating and supervising the manufacturers of medicines and medical devices, ensuring GMP quality requirements are fulfilled.

Above all, it is ultimately the marketing authorization holder’s responsible to meet GMP compliance clearly set by the ICH guidelines, pharmacopoeias and enforced by the regulatory authorities. Read more in our whitepaper.