Asian innovation in pharmaceutical and medical device industry–beyond tomorrow

M Jakovljevic, W Wu, J Merrick, A Cerda… - Journal of medical …, 2021 - Taylor & Francis
The Asian region has passed a long and rocky road during the past several decades to
establish itself as the second leading regional biotech market globally. China has become …

[PDF][PDF] Generic drugs regulations and registration in Indonesia, Malaysia and Vietnam: A drug regulatory case study

DS Sandeep, CR Sowmya, A Narayanan… - Journal of Young …, 2022 - jyoungpharm.org
Objectives: The present study describes the generic drug regulations and registration
process in three ASEAN countries Indonesia, Malaysia and Vietnam. Methods: For the …

An overview of the drug registration requirements for export to Tanzania, Nepal, and Cambodia

TV Shelke, S Khante, MB Sarda, KR Mahadik… - … innovation & regulatory …, 2020 - Springer
In the semiregulated market, different countries have varying requirements of registration for
export to such a specific country or region. The objective of the present study is to give a …

Regulations in ASEAN Countries

M Trivedi, F Ali, K Neha, N Singh… - Global Regulations of …, 2024 - taylorfrancis.com
To tackle the problems caused by illegal drugs in the area, the Association of Southeast
Asian Nations (ASEAN) has been highly active in develo** and enforcing drug policies. A …

Assessment of regulatory requirements and filing procedure of drug master file for Brazil, Europe and South Africa

R Patel, KR Girase, VT Rao, AA Patel… - International Journal Of …, 2022 - indianjournals.com
A Drug Master File is a record that consists of detailed, correct data approximately an Active
Pharmaceutical Ingredient (API) or Dosage Form of a Finished Product (FP). It is a classified …

[PDF][PDF] GENERIC DRUG REGISTRATION AND COUNTRY-SPECIFIC REQUIREMENTS IN SAUDI ARABIA, QATAR, BAHRAIN, AND OMAN

J GUNASEELAN, AS KM - 2024 - academia.edu
Objective: This research aims to examine the regulatory framework and prerequisites for
generic drug registration in the Middle East and North Africa (MENA) region, with a specific …