The pharmaceutical industry is the technology sector with the highest added-value to the industry. According to the 2018, EU/US Industrial R&D Investment Score board, the pharmaceutical and biotechnology sector amounts to 18.9 % of total business R & D expenditure worldwide. The average spending level on new products launched in 2019-2023 is expected to reach to $45.8 billion, slightly greater that the $43.4 billion observed for products launched in 2014-2018. Now a days pharmaceutical industries are developing molecules especially in the specialty segment like, orphan, biologics and oncology areas, thus confirming the trend towards an increasing role of precision medicine where a new treatment is supposed to reach fewer patients. Huge amount of efforts are also going for development of generic products by various companies. The need of common technical documents for market authorisation is also increasing even in developing markets. All these is leading to increased requirements of usage of knowledge in pharmaceutical operations.
Developing a pharmaceutical product had always been a challenge for the pharmacists, when it comes to approval from the various countries in International markets. It was always a challenge in the previous years as the documentation requirements for marketing authorisation (product registration) were largely varying (diversified) as per the individual country’s requirement, not only in regulated market but also semi regulated and emerging markets.
Due to the lack of uniformity amongst the countries in framing the registration documents requirements, the task of Regulatory Pharmacist, always remains challenging. With lot of efforts by International organisations like WHO, ICH and ISO which lead to the need of