In API (Active Pharmaceutical Ingredient) regulatory affairs, the use of abbreviations and short forms is a common practice due to several reasons:
1.
Efficiency in Communication:
Regulatory affairs involve extensive documentation and communication between
various stakeholders, including regulatory bodies, manufacturers, and internal
teams. Short forms help convey complex terms quickly, saving time and effort in
written and verbal communication.
2.
Standardization:
Many abbreviations are standardized across the pharmaceutical industry, making
them universally understood by professionals. This reduces misunderstandings
and ensures consistency in documentation.
3.
Length and Complexity of Terms:
Many terms in regulatory affairs are long and technical, such as "Good
Manufacturing Practices" (GMP) or "Certificate of Suitability to the
Monographs of the European Pharmacopoeia" (CEP). Short forms make these
terms more manageable in daily use.
4.
Volume of Information:
Regulatory professionals deal with a vast amount of data, including guidelines,
dossiers, reports, and correspondence. Short forms help simplify and streamline
the information, making it easier to organize and refer to.
5.
Global Nature of the Industry:
Since the pharmaceutical industry operates globally, abbreviations allow
seamless communication across different regions and regulatory agencies. For
instance, "ICH" (International Council for Harmonisation) is
universally recognized, irrespective of the region.
6.
Documentation Constraints:
Regulatory submissions often have strict format and page limitations. Using
short forms can help comply with these requirements by reducing text length.
7.
Expert Audience:
The primary audience in regulatory affairs—scientists, regulatory authorities,
and industry professionals—are well-versed in these abbreviations. This shared
understanding facilitates concise communication.
While abbreviations enhance efficiency, they can be
a barrier for new professionals or individuals outside the field. This is why
glossaries and context-specific clarification are important tools in regulatory
affairs.
The list of commonly used abbreviations and short
forms in API Regulatory Affairs are -
|
SmPC |
Summary of Product characteristics. |
|
EDQM |
European Directorate for the Quality of Medicines
& HealthCare |
|
EMA |
European Medicines Agency |
|
ACTD |
ASEAN (Association of Southeast Asian Nations
(ASEAN)) Common Technical Dossier. |
|
ANDA |
Abbreviated New Drug Application |
|
BMR |
Batch Manufacturing Record |
|
CDER |
Center for Drug Evaluation and Research |
|
CEP |
Certification of Suitability of European
Pharmacopoeia monographs |
|
CHMP |
Committee for Medicinal Products for Human Use. |
|
CMS |
Concerned Member States |
|
CPP |
Critical Process Parameter |
|
CQA |
Critical Quality Attribute |
|
DUNS |
Data Universal Numbering System |
|
EFTA |
European Free Trade Association |
|
EMA |
European Medicines Agency |
|
FDA |
Food and Drug Administration |
|
FEI |
FDA Food and Drug Administration Establishment
Identifier |
|
GDUFA |
Generic Drug User Fee Amendments |
|
HMA |
Heads of Medicines Agencies |
|
LOA |
Letter of Authorization |
|
MA |
Marketing authorization |
|
MAA |
Marketing Authorisation Applications |
|
MAH |
Marketing authorization Holder/ Customer |
|
MAP |
Marketing Authorisation Procedures |
|
MAPP |
Manual of Policies and Procedures |
|
MMR |
Master Manufacturing Record |
|
MRA |
ASEAN (Association of Southeast Asian Nations
(ASEAN)) Mutual Recognition Arrangements |
|
NDA |
New Drug Application |
|
NDC |
National Drug Code |
|
OGD |
Office of Generic Drugs |
|
OPQ |
Office of Pharmaceutical Quality |
|
PIL |
Patient information leaflet. |
|
QRM |
Quality Risk Management |
|
RLD |
Reference listed drug |
|
RMS |
Reference Member State |
|
RtR |
Ready to Review |