EXPORT REGISTRATION OF PHARMACEUTICALS IN REST OF WORLD COUNTRIES (ROW)

Product registration in rest of world is a challenging task like regulated countries (US, EU & Japan) as they are not harmonized. It creates a difference in regulatory environment in Semi Regulated countries. Enormous diversity of regulatory requirements are found in this area. This region consists of mainly the countries from Asia pacific, Latin America, Eastern Europe, Africa and Gulf countries. Countries from Asia pacific and Gulf have somewhat harmonized their regulatory environment through The Association of Southeast Asian Nations (ASEAN) and Gulf Co-operation Council (GCC) organizations, ROW countries yet to be harmonized regulations in their respective regions. The urgent requirement to rationalize & harmonize regulation was required by instance of rising cost of health care, research & development and to meet the public requirement for safe and efficacious treatments to patient in need. ICH committee has given priority to harmonize the format of reporting data for quality, safety and Efficacy in the application dossier. The commercial significance of ROW markets is increasing globally. It is crucial that pharmaceutical companies keep up-to-date with the latest regulatory developments to ensure their place on the ROW market. This paper favors the regulatory processes for gaining marketing authorization in ROW countries in terms of technical data requirement for the dossier. Keywords: ROW, ASEAN, GCC, BMR, CIS, DMF, TSE/BSE, ICH, F

A review of nanomaterials from synthetic and natural molecules for prospective breast cancer nanotherapy

Breast cancer being one of the most frequent cancers in women accounts for almost a quarter of all cancer cases. Early and late-stage breast cancer outcomes have improved dramatically, with considerable gains in overall survival rate and disease-free state. However, the current therapy of breast cancer suffers from drug resistance leading to relapse and recurrence of the disease. Also, the currently used synthetic and natural agents have bioavailability issues which limit their use. Recently, nanocarriers-assisted delivery of synthetic and natural anticancer drugs has been introduced to the breast cancer therapy which alienates the limitations associated with the current therapy to a great extent. Significant progress has lately been made in the realm of nanotechnology, which proved to be vital in the fight against drug resistance. Nanotechnology has been successfully applied in the effective and improved therapy of different forms of breast cancer including invasive, non-invasive as well as triple negative breast cancer (TNBC), etc. This review presents a comprehensive overview of various nanoformulations prepared for the improved delivery of synthetic and natural anticancer drugs alone or in combination showing better efficacy and pharmacokinetics. In addition to this, various ongoing and completed clinical studies and patents granted on nanotechnology-based breast cancer drug delivery are also reviewed