An overview on comparative study of registration requirements for generics in US, Canada and Europe

Generic Drug Product approval is most stringent and crucial process for company with different rules and regulation in different country. For the registration of the product company has to follow regulatory rules and requirement of country specific agency. Company should apply product marketing authorization as per norms of country requirements and should manage life cycle of that product throughout market. Need to understand and describe the various regulatory requirements for the generic drug approval process and comparison of regulated country. To understand the technical requirements required to market medicines in regulated pharmaceutical market. To evaluate similarities and differences within regulated market of U.S, Canada, and Europe. To understand and evaluate differences of post approval Changes within regulated market.

Switching among branded and generic medication products during ongoing treatment of psychiatric illness

Switches between branded (reference) medications and the corresponding generic medications or between two different corresponding generic medications occur commonly during the treatment of central nervous system disorders. Prescribing a generic product in place of a reference product can reduce patient and pharmacy costs. But there can be implications. Planned or unplanned switches from one product to another during ongoing treatment may introduce variability in drug exposure which could in turn compromise efficacy and/or tolerability. Studies comparing the initiation of reference versus generic products do not provide clear evidence of the superiority of reference or generic products generally, whereas several studies examining a switch between reference and generic products suggest that reductions in efficacy or medication adherence and persistence may be associated with generic substitution. Clinicians should work with patients to facilitate a consistent supply of reference or generic drug product that provides stable exposure to avoid clinical deterioration or poor tolerability.

Regulatory requirement for the approval of Generic Drug in Cambodia as per ASEAN Common Technical Dossier (ACTD)

Drug approval process differs from one country to another country. In some countries only single body regulates the drug as well as responsible for all regulatory work which is a challenging task for the pharmaceutical companies to prepare single dossier that can be simultaneously submitted in many countries for approval. In all countries there is a similar characteristic in regulatory environment but there is a difference in their registration requirements. The purpose of this study is to give a comparative overview on generic drug market regulation in ASEAN Countries Cambodia and Malaysia. The aim of study is to facilitate proper knowledge regarding main critical issues, differences as well as similarities of related drug regulation. There is a different requirement for registration of generic product in each regulatory system but also comprises of some similar outline that includes some common rules. These are variances and regulatory hurdles such as Number of batches for submission in dossier, stability conditions, registration of product, analysis, bioequivalence and clinical study requirement. ASEAN countries for generic drug product approval ACTD submitted to country specific authority. For solid oral dosage forms as per ASEAN guideline there are 4 parts have to be submitted. Part I contains Administrative requirements which is not a part of common technical document. Part II is Quality contains 3 sections that are a) Table of Content b) Quality overall Summary c) Body of data. Part III contains Non clinical. Part IV contains Clinical data. For the generic drug product Part III and Part IV is not required.