Postapproval Changes for Drugs: A Practical Guide
7
Introduction
This chapter reviews the applicable regulatory
requirements for marketing authorization (MA)
transfers, renewals, and other administrative
changes for each of the listed countries.
Argentina (Latin America)
National Administration of Medicines,
Food, and Medical Devices (ANMAT)
ANMAT recognizes two categories of MAs:
1) drug product registration and 2) biological
drug product registration. The drug product
registration process is described in disposition
680/2013. ANMAT has implemented two regu-
lations for biologic product registration, namely
Regulation No. 7075/2011 (14 October 2011)1
and Regulation No. 7729/2011 (14 November
2011).2 Most of the requirements are aligned
with the EU regulations for registration.3
Brazil
Agencia Nacional de Vigilancia Sanitaria
(ANVISA)
Various ANVISA standards characterize the
registration process for new drugs, branded
generics, non-branded generics, and biological
drug products, including the following:
• The ANVISA standard, RDC No. 200/2017
innovative drug products, provides the
registration of new, generic, and similar drug
products.
• The ANVISA standard, RDC No. 55/2010,
provides for the registration of biological
products.
• The ANVISA standard, RDC No. 49/2011,
covers postapproval changes.
Canada
Health Canada (Therapeutic Products
Directorate [TPD])
The TPD recognizes three broad categories of
MAs, i.e., new drug application (NDS), the
abbreviated new drug submission (ANDS), and
generic applications. The regulations governing
generic applications are covered in Food and
Drug Regulations Section C.08.002.1.4
The Centre for Biologics Evaluation (CBE)
is responsible for the regulatory and scien-
tific evaluation of vaccines, allergenic extracts,
albumins, immunoglobulins, coagulation factors
and their inhibitors from human plasma or from
Chapter 2: Argentina, Brazil,
Canada, Chile, and Mexico
By Shakti Tripathy, MPharm
7
Introduction
This chapter reviews the applicable regulatory
requirements for marketing authorization (MA)
transfers, renewals, and other administrative
changes for each of the listed countries.
Argentina (Latin America)
National Administration of Medicines,
Food, and Medical Devices (ANMAT)
ANMAT recognizes two categories of MAs:
1) drug product registration and 2) biological
drug product registration. The drug product
registration process is described in disposition
680/2013. ANMAT has implemented two regu-
lations for biologic product registration, namely
Regulation No. 7075/2011 (14 October 2011)1
and Regulation No. 7729/2011 (14 November
2011).2 Most of the requirements are aligned
with the EU regulations for registration.3
Brazil
Agencia Nacional de Vigilancia Sanitaria
(ANVISA)
Various ANVISA standards characterize the
registration process for new drugs, branded
generics, non-branded generics, and biological
drug products, including the following:
• The ANVISA standard, RDC No. 200/2017
innovative drug products, provides the
registration of new, generic, and similar drug
products.
• The ANVISA standard, RDC No. 55/2010,
provides for the registration of biological
products.
• The ANVISA standard, RDC No. 49/2011,
covers postapproval changes.
Canada
Health Canada (Therapeutic Products
Directorate [TPD])
The TPD recognizes three broad categories of
MAs, i.e., new drug application (NDS), the
abbreviated new drug submission (ANDS), and
generic applications. The regulations governing
generic applications are covered in Food and
Drug Regulations Section C.08.002.1.4
The Centre for Biologics Evaluation (CBE)
is responsible for the regulatory and scien-
tific evaluation of vaccines, allergenic extracts,
albumins, immunoglobulins, coagulation factors
and their inhibitors from human plasma or from
Chapter 2: Argentina, Brazil,
Canada, Chile, and Mexico
By Shakti Tripathy, MPharm