Professional Documents
Culture Documents
United States food Starting from May, 2017, all new Drug Master File
and drug (DMFs), all documents submitted to existing
administration DMFs, must be submitted in an electronic
(USFDA) Common Technical Document (eCTD).
Labeling
Health Canada Releases a plain language labeling guidance. For non-prescription products, the Regulations
apply as of June 13, 2017; emphasizing the safety through labeling for Prescription drugs,
Health Canada has released a guidance document for Plain Language Labeling which came
into effect from June 13, 2015.
Therapeutic Goods New labeling requirements for medicines supplied in Australia. These changes will be
Administration implemented over four years from 31 August 2016.
(TGA)
The announcement was made following extensive consultation on changes to Therapeutic
Goods Order No. 69 - General requirements for labels of medicines (TGO69).
Labeling requirements have been split into two new labeling Orders:
TGO 91 - Standard for labels of prescription and related medicines (TGO91)
TGO 92 - Standard for labels of non-prescription medicines (TGO92)
This split was applied to better consider the different risk levels for prescription and
non-prescription medicines and also to improve overall readability.
TGO 91 and TGO 92 are registered on the Federal Register of Legislation and a new guidance
document is available to assist you in complying with the new requirements.
The South African These Orders will come into effect on 31 August 2016, which will start the four year transition
Medicine Control period.
Council (MCC)
Transition period - what sponsors need to do
The four year transition period for these changes will start on 31 August 2016 and end on 31
August 2020. During this time, you can choose to comply with the old labeling requirements
under TGO 69 or the new labeling requirements under TGO 91/92 (whichever applies).
Labels must fully comply with all requirements of either the old or the relevant new Order. A
label cannot selectively comply with parts of multiple Orders.
After the 4 year transition, all medicines must comply with either TGO 91 or TGO 92.
The Pharmacy and The PPB revised its Guidelines for Conduct of Clinical Trials in Kenya. The document is
Poisons Board intended to provide guidance on the format and contents of application for authorization to
(PPB) conduct clinical trials in Kenya, the amendments to clinical trial application and the
declarations at the end of a clinical trial and the revised guideline was effective from
September, 2016.