Regulatory Submission Requirements for Manufacturing of Parenteral Products in China

Abstract

Parenteral products are used widely nowadays, with the recent innovation in manufacturing process and packaging material and container it is easy to keep them pure and safe throughout the product life-cycle. China is also been a very important market for the parenteral and also for generic pharmaceutical products. China is currently developing its strategies and laws for the handling of pharmaceutical product to make them safer and top of the quality. They are developing their guidelines with the reference from developed countries like USA and EU, because of this reason there are much similarities between the pharmacopoeial standards of china and US, EU. The thesis involves some of the manufacturing tests which are required to identify the safety and integrity of the product with the packaging system. It also includes different classification system of drug as per registration process and general technical requirement for the injections. It also includes the pharmaceutical package registration which is required for china. Thesis also includes the comparison of the general chapter of USP, CP and Ph. Eur. Later it focuses on Bio-equivalence study requirement for the special drug (Liposomal) injections with the example of three drugs which are Amphotericin B, Doxorubicin HCl and Fulvestrant Liposomal Injection. It also includes data required for BE notification and data required for the registration dossier.