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World Journal of Pharmaceutical
and Medical Research

An International Peer Reviewed Journal for Pharmaceutical and Medical Research and Technology
An Official Publication of Society for Advance Healthcare Research (Reg. No. : 01/01/01/31674/16)
ISSN 2455-3301
IMPACT FACTOR: 4.639

ICV : 78.6

Abstract

GENERAL OVERVIEW OF DRUG REGISTRATION REQUIREMENTS FOR MALAYSIA

Sai Vyshnavi A, *Jyothshna Devi Katamreddy, Jayachandra Reddy. P.

ABSTRACT

Regulatory requirements are different from country to country mainly the administrative content of the dossier. Some of the regulated market country (US, EU, MCC, TGA) guideline are very stringent compared to Semi Regulated Market countries (India, Singapore, Malaysia, Thailand, Russia). Regulatory Affairs in malaysia is bit compound process need to cognize the current regulations in emerging markets and one step forward towards standardization vs. localization. Since localization is critical to access and develop individual regulatory strategies for doing business are the most common reasons of failure of MNCs in the emerging markets to uptake the markets. Regulatory environment define the market dynamics and healthcare system. Patient has been evolved as center point of health care system and policies around the globe. Therefore the article outlines the awareness of drug regulation in Malaysia and how changes are evolving and what implications of these changed dimensions are necessary.

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