International Journal of Drug Regulatory Affairs (IJDRA)

Table of Contents

• REVIEW ARTICLE

  A Comprehensive and Comparative study of qualification process for Drug Development tools in US, Europe, Japan and India

  • Author: Garima Kshatriya, Dilip G. Maheshwari
  • DOI: 10.22270/ijdra.v6i2.227

• Differentiation between the Regulatory paths placed on Mouthwashes in the US and EU

  • Author: Philip Saddik, John Pappan
  • DOI: 10.22270/ijdra.v6i2.229

• Regulatory requirements for Dossier submission in African Countries (Kenya, Uganda, and Tanzania)-A Review

  • Author: Randeria Juhi, Ronak Dedania, Zarna Dedania, Vineet Jain, Danej Meghna
  • DOI: 10.22270/ijdra.v6i2.231

• Current Regulatory requirements for Registration of Nutraceuticals in India and USA

  • Author: Pooja N. Jain, Meera H Rathod, C Vineet Jain, S. M. Vijayendraswamy
  • DOI: 10.22270/ijdra.v6i2.232

• Regulatory requirements for the approval of Anti-Cancer drug (Mercaptopurine)in Myanmar as per ACTD

  • Author: Meera H. Rathod, Pooja N. Jain, Vineet C. Jain, S.M. Swamy Vijyendra
  • DOI: 10.22270/ijdra.v6i2.235

• Regulatory requirements for Drug master file in context to Canada and Australia

  • Author: Danej Meghna, Ronak Dedania, Sanket Gandhi, Randeria Juhi, Kankrej Gaurav
  • DOI: 10.22270/ijdra.v6i2.236

• A retrospective study of Warning Letters issued by US FDA over 2015–2017

  • Author: Lakshmi Ananth, Nirmal K. Gurbani, Saurabh Kumar, Bharat Gujavarti
  • DOI: 10.22270/ijdra.v6i2.242

• Regulation of Medicines in Bhutan: Current Status, Challenges and Opportunities

  • Author: Pelden Chejor, Jigme Tenzin, Jigme Dorji
  • DOI: 10.22270/ijdra.v6i2.243

• General requirements for marketing authorization transfers in Thailand, Malaysia, Singapore, Indonesia and Philippines

  • Author: Prathyusha Jeeva, Jyothshna Devi Katamreddy
  • DOI: 10.22270/ijdra.v6i2.244