International Journal Of Drug Regulatory Affairs

Table of Contents

• REVIEW ARTICLE

  FDA’s new pharmaceutical quality initiative: Knowledge-aided assessment & structured applications

  • Author: Palak Govani, Krupa Bahekar, Vinit Movaliya, Khushboo Vaghela, Niranjan Kanki, Shrikalp Deshpande, Maitreyi Zaveri
  • DOI: 10.22270/ijdra.v10i4.523

• Survey of the Jan pariyojana scheme in India and its impact on citizens during the previous decade

  • Author: Evesh Kaul, Priyanka Gupta
  • DOI: 10.22270/ijdra.v10i4.537

• Regulatory prospective on software as a medical device

  • Author: Foram Chothani, Vinit Movaliya, Khushboo Vaghela, Maitreyi Zaveri, Shrikalp Deshpande, Niranjan Kanki
  • DOI: 10.22270/ijdra.v10i4.545

• Comparisons of registration requirements of Nutraceuticals in Philippines, Tanzania, Cambodia and India

  • Author: Khushali Patel, Utsav Patel, Khushboo Vaghela, Niranjan Kanki, Maitreyi Zaveri, Vinit Movaliya
  • DOI: 10.22270/ijdra.v10i4.546

• The legal and institutional framework of market surveillance and the fight against spurious, falsely labelled, falsified or counterfeit product in West Africa: The case of togo

  • Author: Sandra Wotsa Vidjro, Fatima Guiet Mati, Serge-Antoine Amari, Jean-Yves Pabst
  • DOI: 10.22270/ijdra.v10i4.555

• How to write standard operating procedures: Values and a practical guide

  • Author: Kidanemariam G Michael Beyene, Solomon Shiferaw Nadew, Wassu Gedefaw Ali, Awot Gebregzabiher Gebrehiwot, Solomon Getachew Atsibeha
  • DOI: 10.22270/ijdra.v10i4.557

• Global medical device nomenclature: Basic concept and five-year strategy

  • Author: Ayesha Siddikha, K. S. L. Vidyadhari, M. Beulah Manasa, N.L. Prasanthi, K. Venkateswara Raju
  • DOI: 10.22270/ijdra.v10i4.560

• A study of regulatory aspects on registration of orphan drugs in US and EU

  • Author: S. Vasantha Mounika, P. Ramya, M.S.L. Divya, S. Naga Swaroopa, K. Venkateswara Raju, N.L. Prasanthi
  • DOI: 10.22270/ijdra.v10i4.563

• Analysis of emergency drug approval system in china and the United States under Public Health emergencies and its enlightenment to China

  • Author: Wei Chen, Yi Liang
  • DOI: 10.22270/ijdra.v10i4.564

• RESEARCH ARTICLE

  Research on quality control strategy of CAR-T cell therapy products based on QbD

  • Author: Wei Chen, Wenmiao Tian, Yi Liang
  • DOI: 10.22270/ijdra.v10i4.565

• REVIEW ARTICLE

  Pharmaceutical regulation in niger in 2021: Significant advances with the harmonization process

  • Author: Fatima Guiet Mati, Ousmane Abdoulaye, Cinthia Amonkou-N'guessan Anne, Jean-Marie Trapsida, Maty Elh Mamane, Issaka Sonde, Serge Antoine Amari, Jean-Yves Pabst
  • DOI: 10.22270/ijdra.v10i4.566

• A comparative study of regulations of cell and gene therapy in US, EU and India

  • Author: A. Tejaswini, N.L. Prasanthi, K. Venkateswara Raju
  • DOI: 10.22270/ijdra.v10i4.569