RoundupsRoundups
Asia-Pacific Roundup: Medsafe updates overview of new and changed medicine regulation
Posted 31 January 2023 By Nick Paul Taylor
Medsafe also has updated the list of what it expects sponsors to have to ensure the supply of safe and effective medicines and timely responses to stakeholders. The list now includes staff available in New Zealand business hours to engag...
RoundupsRoundups
Asia-Pacific Roundup: WHO warns on contaminated cough syrups linked to child deaths
Posted 17 January 2023 By Nick Paul Taylor
“WHO requests increased surveillance and diligence within the supply chains of countries and regions likely to be affected by these products. Increased surveillance of the informal/unregulated market is also advised. National regulatory ...
RoundupsRoundups
Asia-Pacific Roundup: Malaysia queries on requirements for medical device certificate applications
Posted 03 January 2023 By Nick Paul Taylor
The expanded scope is reflected in a section that features tables of requirements for obtaining medical device certificates. The existing document features one table that lists requirements companies need to meet when filing for CFS for ...
RoundupsRoundups
Asia-Pacific Roundup: New Zealand’s Medsafe retains classification of low-dose CBD
Posted 06 December 2022 By Nick Paul Taylor
In its review, Medsafe’s committee considered TGA’s rationale and the evidence behind the decision. The review also looked at regulatory advice from Medsafe and the Medicinal Cannabis Agency and five comments it received after announcing...
RoundupsRoundups
Asia-Pacific Roundup: Malaysia’s MDA updates guidance on labeling, change notifications for devices
Posted 22 November 2022 By Nick Paul Taylor
Malaysia’s Medical Device Authority (MDA) has updated its guidance on the requirement for labeling of medical devices and the handling of change notifications of authorized products. MDA published the fifth edition of the labeling guidan...
RoundupsRoundups
Asia-Pacific Roundup: Malaysia’s MDA posts draft guidance on custom-made medical devices
Posted 01 November 2022 By Nick Paul Taylor
MDA explains the proposed general requirements for custom-made medical devices, which are intended for specific patients and manufactured in accordance with a written prescription. The written prescription must include the name of the pa...
RoundupsRoundups
Asia-Pacific Roundup: TGA issues draft guidance on pathways for borderline products
Posted 11 October 2022 By Nick Paul Taylor
Existing guidance from 2005 needs to be updated because of significant changes that have occurred since then, including the introduction of the biological regulatory framework and the creation of emerging types of products, according to ...
RoundupsRoundups
Asia-Pacific Roundup: Medsafe grants provisional approval to Novavax COVID vaccine
Posted 23 August 2022 By Jeff Craven
New Zealand joins other countries that have authorized or approved Nuvaxovid. The vaccine has been granted provisional approval by the Therapeutic Goods Administration (TGA), received marketing approval from the Japan Ministry of Hea...
RoundupsRoundups
Asia-Pacific Roundup: Malaysian device authority posts code of ethics and conduct
Posted 09 August 2022 By Nick Paul Taylor
Malaysia’s Medical Device Authority (MDA) has released a code of ethics and conduct that describes its approach to subjects such as conflicts of interest, confidentiality and the receipt of gifts.
RoundupsRoundups
Asia-Pacific Roundup: TGA focuses on continuous improvement in latest business plan
Posted 02 August 2022 By Nick Paul Taylor
Australia’s Therapeutic Goods Administration (TGA) has adopted four strategic objectives as part of its business plan for its 2022-23 financial year. The document sets TGA’s product regulation, stakeholder engagement and compliance and i...
RoundupsRoundups
Asia-Pacific Roundup: Malaysia’s NPRA details pilot project for track and trace system
Posted 26 July 2022 By Nick Paul Taylor
According to NPRA, the system is designed to ensure the supply chain only contains products registered with the Ministry of Health; ensure the availability of supplies and improve distribution efficiency; terminate existing security labe...
RoundupsRoundups
Asia-Pacific Roundup: TGA posts 2022-2023 priorities for import, advertising, supply compliance
Posted 19 July 2022 By Nick Paul Taylor
The list includes seven compliance priorities. First up: to “deter and address the unlawful import, advertising and supply of unapproved therapeutic goods associated with COVID-19.” To do so, TGA will provide information to the community...
     
  •  
  • 1
  •  
  • 2
  •  
  •  
Virtual ProgramsVirtual Programs
RAPS Webcast: Get Certified in Regulatory Affairs: Get Your RAC!
Friday, 03 March 2023 (1:00 - 2:00PM) 1.0 RAC Credits Price: Free
This webcast will answer top Regulatory Affairs Certification (RAC) questions. By attending, regulatory professionals will decide if earning a RAC is right for them and how to proceed.
Virtual ProgramsVirtual Programs
RAPS Webcast: Get Certified in Regulatory Affairs: Get Your RAC!
Friday, 05 May 2023 (1:00 - 2:00PM) 1.0 RAC Credits Price: Free
This webcast will answer top Regulatory Affairs Certification (RAC) questions. By attending, regulatory professionals will decide if earning a RAC is right for them and how to proceed.
Virtual ProgramsVirtual Programs
RAPS Webcast: Get Certified in Regulatory Affairs: Get Your RAC!
Friday, 08 September 2023 (1:00 - 2:00PM) 1.0 RAC Credits Price: Free
This webcast will answer top Regulatory Affairs Certification (RAC) questions. By attending, regulatory professionals will decide if earning a RAC is right for them and how to proceed.

Books   |   Learning

RAC ExamRAC Exam
RAC Devices Examination Autumn 2023
Member: $495.00 Nonmember: $625.00
Testing Window :
30 October 2023 To 8 December 2023
Registration Deadline : 5 October 2023
RAC ExamRAC Exam
RAC Devices Examination Spring 2023
Member: $495.00 Nonmember: $625.00
Testing Window : 20 March 2023 To 28 April 2023
Registration Deadline : 23 February 2023
RAC ExamRAC Exam
RAC Devices Examination Summer 2023
Member: $495.00 Nonmember: $625.00
Testing Window : 10 July 2023 To 18 August 2023
Registration Deadline : 15 June 2023
RAC ExamRAC Exam
RAC Drugs Examination Autumn 2023
Member: $495.00 Nonmember: $625.00
Testing Window :
30 October 2023 To 8 December 2023
Registration Deadline : 5 October 2023
RAC ExamRAC Exam
RAC Drugs Examination Spring 2023
Member: $495.00 Nonmember: $625.00
Testing Window : 20 March 2023 To 28 April 2023
Registration Deadline : 23 February 2023
RAC ExamRAC Exam
RAC Drugs Examination Summer 2023
Member: $495.00 Nonmember: $625.00
Testing Window : 10 July 2023 To 18 August 2023
Registration Deadline : 15 June 2023
Virtual ProgramsVirtual Programs
RAPS Webcast: Get Certified in Regulatory Affairs: Get Your RAC!
Friday, 08 September 2023 (1:00 - 2:00PM)
1.0RAC Credits
Price: Free
This webcast will answer top Regulatory Affairs Certification (RAC) questions. By attending, regulatory professionals will decide if earning a RAC is right for them and how to proceed.
Virtual ProgramsVirtual Programs
RAPS Webcast: Get Certified in Regulatory Affairs: Get Your RAC!
Friday, 05 May 2023 (1:00 - 2:00PM)
1.0RAC Credits
Price: Free
This webcast will answer top Regulatory Affairs Certification (RAC) questions. By attending, regulatory professionals will decide if earning a RAC is right for them and how to proceed.
Virtual ProgramsVirtual Programs
RAPS Webcast: Get Certified in Regulatory Affairs: Get Your RAC!
Friday, 03 March 2023 (1:00 - 2:00PM)
1.0RAC Credits
Price: Free
This webcast will answer top Regulatory Affairs Certification (RAC) questions. By attending, regulatory professionals will decide if earning a RAC is right for them and how to proceed.