Changing Regulatory Landscape of

preceding and forthcoming Years

Dealing with current and upcoming biopharma regulations have never been as
tough and challenging as these days. We have lot of regulatory intelligence
tools in the market simultaneously never been so simple to handle with most
frequent changing regulatory policies, amendments or requirements of the
authorities. Taking off many guidelines to be amenable across the world, Global Drug Regulatory Intelligence
various drug regulatory authorities released guidelines or policies.

In this Newsletter, we have compiled and simplified some of these new

policies, revisions, regulatory amendments from registration, labeling, safety
reporting, renewal, publishing /eCTD submission of last year and forthcoming
years for our subscribers:

Authority Regulatory Change or a rule

Health Canada In a notice posted to its website, Health Canada

gave advance warning that the agency is
considering an eCTD filing requirement, or eCTD
mandate, that would take effect as early as
January 1, 2018.

The eCTD format filing requirement would apply

to the following regulatory activity types:
New Drug Submission (NDS)
Supplement to a New Drug Submission SNDS)
Abbreviated New Drug Submission (ANDS)
Supplement to an Abbreviated New Drug
Submission (SANDS)

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 Authority Regulatory Change or a rule Quickly find critical regulatory
guidelines, clinical scientific,
Health Canada has been accepting regulatory competitive and regulatory
submissions in eCTD format since 2004 procedures to make the best
however reaching towards a common decisions for your regulatory filings.
submission intake process, as well as intending
to stay aligned with other regulatory authorities, Presents manually curated
Health Canada is revising the existing regulatory data across the tool
requirements. supports to know global regulations
very easily and keep life science
professionals up to date with the
The South African October, 2016: The South African Medicine
constantly changing / evolving
Medicine Control Control Council (MCC) updated its Specification
regulatory environment with an
Council (MCC) for electronic Common Technical Document
easy access to continuously
(eCTD) Regional-Module 1 intended to provide
updated accurate drug regulatory
requirements to applicants wishing to submit
information.
applications for the registration of medicines in
eCTD format.
Add the additional insights of Our
global regulatory experts to your
This document specifies Module 1 of the
custom research projects.
electronic Common Technical Document
(eCTD) for South Africa (ZA). MCC has
deadline till 30 April 2017, for both the versions of
South African Module 1 specifications for eCTD.
If by chance the eCTD submissions made after 1
May 2017 do not comply with the South African
Module 1 specification for eCTD V2.0, the
applications will not be accepted.

The Saudi Food Baseline eCTD Submission mandatory for any

and Drug Authority new regulatory activities (initial registration,
(SFDA) renewal or variation etc.), from January 2017.

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).

FDA eyes mandatory eCTD format for certain

submissions types beginning May 5, 2017,
submission types namely,
New Drug Applications (NDA),
Abbreviated New Drug Applications (ANDA),
Biological License Applications (BLA) and
Master Files must be submitted in the eCTD
format. However, for all commercial
Investigational New Drug submissions (IND), the
deadline is set for May 5, 2018.

Labeling

The China Food New packaging requirements: From July 2017

and Drug cosmetic products must be labeled with the new
Administration label. The products and packaging must not be
(CFDA) labeled with the QS mark. Cosmetics
manufacturers could mark their registered
products with the old label on the packaging till
30th June 2017. Even if, the products which are
already packaged can be made available in the
market till the expiration date after which they
need to comply with new packaging requirements.

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 Authority Regulatory Change or a rule

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.

This report is brought to you by VISTAAR- Global Regulatory Intelligence

Please reach us at vistaar@makrocare.com to discuss on your Tactical or Strategic Reg-Intel needs.

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