2 Regulatory Affairs Professionals Society (RAPS)
Fundamentals of Pharmaceutical and Biologics Regulations: A Global Perspective
• collaborating with foreign regulators and other stakeholders
• developing harmonized standards and standards convergence
• educating industry representatives about its requirements and
• increasing transparency and accountability in the supply chain
Several offices within FDA address global issues. The Office of
Regulatory Affairs (ORA) inspects and reviews products offered
for entry into the US. The agency’s product centers implement
the policies and outreaches that touch their product portfolios.
The Office of Global Policy and Strategy (OGPS) serves as a
pan-agency coordinator, information distributor, and access point
for multilateral organizations like the World Health Organiza-
tion. OGPS also addresses international trade of regulated prod-
ucts and mutual recognition agreements, facilitates information
sharing with its global counterparts, and manages FDA’s foreign
offices worldwide.3
The Office of International Products (OIP) coordinates the
FDA’s international work, which helps foster partnerships with
counterpart foreign agencies and international organizations. OIP
offices around the world focus on specific regions: Latin America
(Costa Rica), Europe (Brussels, London), China (Beijing), and
India (New Delhi).
International Arrangements
FDA uses various tools to set up partnerships with other nations
to promote product safety, and they fall into two categories of
international arrangements: Cooperative Arrangements and
Confidentiality Commitments.7 A Confidentiality Commitment
sets up the legal framework for the FDA to share certain kinds of
non-public information with international organizations and regu-
lators in other countries as part of cooperative law enforcement or
regulatory activities.
A Cooperative Arrangement is a written document that de-
scribes the good-faith intentions of the FDA, other regulators, and
international organizations to engage in cooperative activities.
Parallel Scientific Advice
Another globalized approach shared by the EMA and the FDA
is establishing a mechanism for experts to concurrently engage
in scientific discourse with sponsors on key issues during the
development phase of new medicinal products (drugs, biologicals,
vaccines, advanced therapies, nanotechnology, and pediatric drug
development). It helps the pharmaceutical industry and regulatory
agencies proactively engage early in product development.
Cluster Calls
Various health authorities, including FDA, EMA, Health Canada,
the Japanese Pharmaceuticals and Medical Devices Agency
(PMDA), and Australian Therapeutic Goods Administration
(TGA), also have developed a process called ‘cluster calls’ to allow
for increased collaboration and discussion of important topics in
areas such as advanced therapies (e.g., cell and tissue products),
biosimilars, blood safety, oncology-hematology products and non-
clinical oncology products, orphan products, patient engagement,
pediatric products, pharmacogenomics, pharmacometrics (model-
ing and simulation), pharmacovigilance, rare diseases, vaccines, and
veterinary medical products. (Not all of these agencies necessarily
participate in all clusters.)
FDA also is a member or participant in several international
organizations, including the International Council for Harmon-
isation, Pharmaceutical Inspection Convention, Pharmaceutical
Inspection Co-operation Scheme, International Medical Device
Regulators Forum, and Codex Alimentarius, which promotes
international food standards.
In addition to its own programs, FDA collaborates exten-
sively with other HHS and federal agencies on international
issues. Within HHS, the Office of Global Affairs (OGA) works
with FDA and other agencies on such issues as trade and health,
emerging infectious diseases and global health security, phar-
maceutical pricing and reimbursement, and tobacco control
and nutrition. In their own words, “they foster critical global
relationships, coordinate international engagement across HHS
and the U.S. government, and provide leadership and expertise
in global health diplomacy and policy to contribute to a safer,
healthier world.” OGA collaborates with the US Department
of State and serves as the US government’s liaison to the World
Health Organization.
European Medicines Agency
The European Medicines Evaluation Agency (EMEA) was
founded in 1995. It worked across the European Union (EU)
nations to protect human and animal health by evaluating
human and veterinary medicines as their primary focus. It also
provided partners and stakeholders with independent, unbiased,
science-based information on medicines.8 The name was changed
to European Medicines Agency (EMA) in late 2009.9 The main
objective for establishing EMA was to have a harmonized process
among the regulatory bodies of different member states within the
EU. The agency also is responsible for products developed in the
specialized areas of medicines for rare diseases, herbal medicines,
medicines for children, and advanced therapy medicines. Up until
2020, the UK hosted EMA. Because the UK left the EU on 31
January 2020, the EMA headquarters moved to Amsterdam in
March 2019.10
What is unique about EMA is the dual nature in which a
medicinal product may be authorized. In the EU, all medicines
must have a marketing authorization (MA) before they can be
used by patients. There are two ways of obtaining this authoriza-
tion. Under the Centralised Procedure, EMA gives an opinion,
resulting in a single MA for the whole of the EU. Under national
MA procedures, individual member states authorize the medi-
cines for use in their territory.11 Most medicinal products for hu-
man and veterinary use – including those derived from biotech-
nology and other high-technology methods, human medicines
for HIV/AIDS, cancer, diabetes, or neurodegenerative diseases,
and all designated orphan medicines – are to be approved by the
Centralised Procedure.
EMA is governed by an independent Management Board
composed of 36 independent members. The board’s role is to
define EMA’s budget, develop the yearly work plan and ensure the
Fundamentals of Pharmaceutical and Biologics Regulations: A Global Perspective
• collaborating with foreign regulators and other stakeholders
• developing harmonized standards and standards convergence
• educating industry representatives about its requirements and
• increasing transparency and accountability in the supply chain
Several offices within FDA address global issues. The Office of
Regulatory Affairs (ORA) inspects and reviews products offered
for entry into the US. The agency’s product centers implement
the policies and outreaches that touch their product portfolios.
The Office of Global Policy and Strategy (OGPS) serves as a
pan-agency coordinator, information distributor, and access point
for multilateral organizations like the World Health Organiza-
tion. OGPS also addresses international trade of regulated prod-
ucts and mutual recognition agreements, facilitates information
sharing with its global counterparts, and manages FDA’s foreign
offices worldwide.3
The Office of International Products (OIP) coordinates the
FDA’s international work, which helps foster partnerships with
counterpart foreign agencies and international organizations. OIP
offices around the world focus on specific regions: Latin America
(Costa Rica), Europe (Brussels, London), China (Beijing), and
India (New Delhi).
International Arrangements
FDA uses various tools to set up partnerships with other nations
to promote product safety, and they fall into two categories of
international arrangements: Cooperative Arrangements and
Confidentiality Commitments.7 A Confidentiality Commitment
sets up the legal framework for the FDA to share certain kinds of
non-public information with international organizations and regu-
lators in other countries as part of cooperative law enforcement or
regulatory activities.
A Cooperative Arrangement is a written document that de-
scribes the good-faith intentions of the FDA, other regulators, and
international organizations to engage in cooperative activities.
Parallel Scientific Advice
Another globalized approach shared by the EMA and the FDA
is establishing a mechanism for experts to concurrently engage
in scientific discourse with sponsors on key issues during the
development phase of new medicinal products (drugs, biologicals,
vaccines, advanced therapies, nanotechnology, and pediatric drug
development). It helps the pharmaceutical industry and regulatory
agencies proactively engage early in product development.
Cluster Calls
Various health authorities, including FDA, EMA, Health Canada,
the Japanese Pharmaceuticals and Medical Devices Agency
(PMDA), and Australian Therapeutic Goods Administration
(TGA), also have developed a process called ‘cluster calls’ to allow
for increased collaboration and discussion of important topics in
areas such as advanced therapies (e.g., cell and tissue products),
biosimilars, blood safety, oncology-hematology products and non-
clinical oncology products, orphan products, patient engagement,
pediatric products, pharmacogenomics, pharmacometrics (model-
ing and simulation), pharmacovigilance, rare diseases, vaccines, and
veterinary medical products. (Not all of these agencies necessarily
participate in all clusters.)
FDA also is a member or participant in several international
organizations, including the International Council for Harmon-
isation, Pharmaceutical Inspection Convention, Pharmaceutical
Inspection Co-operation Scheme, International Medical Device
Regulators Forum, and Codex Alimentarius, which promotes
international food standards.
In addition to its own programs, FDA collaborates exten-
sively with other HHS and federal agencies on international
issues. Within HHS, the Office of Global Affairs (OGA) works
with FDA and other agencies on such issues as trade and health,
emerging infectious diseases and global health security, phar-
maceutical pricing and reimbursement, and tobacco control
and nutrition. In their own words, “they foster critical global
relationships, coordinate international engagement across HHS
and the U.S. government, and provide leadership and expertise
in global health diplomacy and policy to contribute to a safer,
healthier world.” OGA collaborates with the US Department
of State and serves as the US government’s liaison to the World
Health Organization.
European Medicines Agency
The European Medicines Evaluation Agency (EMEA) was
founded in 1995. It worked across the European Union (EU)
nations to protect human and animal health by evaluating
human and veterinary medicines as their primary focus. It also
provided partners and stakeholders with independent, unbiased,
science-based information on medicines.8 The name was changed
to European Medicines Agency (EMA) in late 2009.9 The main
objective for establishing EMA was to have a harmonized process
among the regulatory bodies of different member states within the
EU. The agency also is responsible for products developed in the
specialized areas of medicines for rare diseases, herbal medicines,
medicines for children, and advanced therapy medicines. Up until
2020, the UK hosted EMA. Because the UK left the EU on 31
January 2020, the EMA headquarters moved to Amsterdam in
March 2019.10
What is unique about EMA is the dual nature in which a
medicinal product may be authorized. In the EU, all medicines
must have a marketing authorization (MA) before they can be
used by patients. There are two ways of obtaining this authoriza-
tion. Under the Centralised Procedure, EMA gives an opinion,
resulting in a single MA for the whole of the EU. Under national
MA procedures, individual member states authorize the medi-
cines for use in their territory.11 Most medicinal products for hu-
man and veterinary use – including those derived from biotech-
nology and other high-technology methods, human medicines
for HIV/AIDS, cancer, diabetes, or neurodegenerative diseases,
and all designated orphan medicines – are to be approved by the
Centralised Procedure.
EMA is governed by an independent Management Board
composed of 36 independent members. The board’s role is to
define EMA’s budget, develop the yearly work plan and ensure the