Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Concept Videos

Protein Import into the Peroxisomes01:27

Protein Import into the Peroxisomes

5.4K
Cells contain membrane-bound organelles called peroxisomes that oxidize organic molecules by transferring hydrogen atoms to oxygen, producing hydrogen peroxide. Peroxisomes enzymatically convert the released hydrogen peroxide into water and oxygen.
Peroxisomal Protein Import:
Peroxisomes lack the genetic machinery required to code for their own proteins. Hence, most peroxisomal membrane, lumenal and transmembrane proteins are synthesized in the cytoplasm or ER and transported to the peroxisome...
5.4K
ABC Transporters: Importer01:27

ABC Transporters: Importer

3.5K
ATP-binding cassette or ABC transporters are a class of ATP-driven pumps that hydrolyze ATP to move solutes across the membrane. They can be grouped into importers and exporters. While exporters are present in all domains of life, importers exist only in bacteria and some plants.
In bacteria, based on the number of transmembrane helices and the chemical nature of their substrates, the ABC importers can be divided into three types:
3.5K
Nuclear Localization Signals and Import01:46

Nuclear Localization Signals and Import

7.8K
Proteins targeted to the nucleus carry short stretches of amino acid sequences called the nuclear localization signal or NLS. Classical nuclear localization signals are of two types: monopartite and bipartite NLS. Monopartite classical NLS (cNLS) consists of a single cluster of 4-8 amino acids. Bipartite cNLS consists of two clusters of  2-3 amino acids and a 9-12 residue long proline-rich linker bridging the two clusters. Signal clusters are rich in positively charged amino acids such as...
7.8K
Guidelines and Strategies for Safe Computer Charting01:18

Guidelines and Strategies for Safe Computer Charting

2.7K
The guidelines and strategies provided by the American Nurses Association (ANA) and the Canadian Nurses Association (CNA) offer essential principles for ensuring safe and secure computer charting systems in healthcare settings. Let's break down each recommendation:
Maintain Confidentiality and Security:
2.7K
Microorganisms in Medicine and Therapeutics01:29

Microorganisms in Medicine and Therapeutics

1.1K
Microorganisms play a fundamental role in vaccine development, gene therapy, and therapeutic production. Their biological properties are harnessed to advance medicine and public health. Beyond immunization, microorganisms contribute to gut health, antibiotic synthesis, and genetic disease treatment.Live Attenuated and Inactivated VaccinesLive attenuated vaccines, such as the measles, mumps, and rubella (MMR) vaccine, utilize weakened forms of pathogens to closely resemble natural infections.
1.1K
Characteristics of Practical Op Amps01:16

Characteristics of Practical Op Amps

869
A difference amplifier, a crucial component in numerous electronic devices, ideally amplifies only the difference-mode signal, which is the difference between two input signals. However, in practical circuits, the output voltage depends on both the differential gain and the common-mode gain.
The ratio of differential gain to the common-mode gain is defined as the common-mode rejection ratio (CMRR). This ratio quantifies the ability of operational amplifiers (op-amps) to reject common-mode...
869

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Historical data analyses and scientific knowledge suggest complete removal of the abnormal toxicity test as a quality control test.

Journal of pharmaceutical sciences·2014
Same author

Forced degradation of therapeutic proteins.

Journal of pharmaceutical sciences·2011
See all related articles

Related Experiment Video

Updated: Feb 5, 2026

Polymalic Acid-based Nano Biopolymers for Targeting of Multiple Tumor Markers: An Opportunity for Personalized Medicine?
14:20

Polymalic Acid-based Nano Biopolymers for Targeting of Multiple Tumor Markers: An Opportunity for Personalized Medicine?

Published on: June 13, 2014

17.1K

Import Testing: An Outdated Practice? Opportunities for Improved Access to Safe and Efficient Medicines.

Joerg H O Garbe1, Maria G Jacobs2, Stephan K Rönninger3

  • 11 F. Hoffmann-La Roche Ltd, Basel, Switzerland.

Therapeutic Innovation & Regulatory Science
|September 21, 2018
PubMed
Summary

Import testing of medicines offers minimal value for drug quality and safety. Postmarketing surveillance is a more effective strategy for managing risks like counterfeits and supply chain issues.

Keywords:
counterfeitsglobal regulatory convergenceimport testingquality management system (QMS)supply interruptionssurveillance testing

More Related Videos

High-Efficiency Generation of Antigen-Specific Primary Mouse Cytotoxic T Cells for Functional Testing in an Autoimmune Diabetes Model
11:31

High-Efficiency Generation of Antigen-Specific Primary Mouse Cytotoxic T Cells for Functional Testing in an Autoimmune Diabetes Model

Published on: August 16, 2019

8.5K
Efficient Techniques for Comprehensive Sampling of Accessible Tissues in Adult Xenopus
08:36

Efficient Techniques for Comprehensive Sampling of Accessible Tissues in Adult Xenopus

Published on: June 10, 2025

752

Related Experiment Videos

Last Updated: Feb 5, 2026

Polymalic Acid-based Nano Biopolymers for Targeting of Multiple Tumor Markers: An Opportunity for Personalized Medicine?
14:20

Polymalic Acid-based Nano Biopolymers for Targeting of Multiple Tumor Markers: An Opportunity for Personalized Medicine?

Published on: June 13, 2014

17.1K
High-Efficiency Generation of Antigen-Specific Primary Mouse Cytotoxic T Cells for Functional Testing in an Autoimmune Diabetes Model
11:31

High-Efficiency Generation of Antigen-Specific Primary Mouse Cytotoxic T Cells for Functional Testing in an Autoimmune Diabetes Model

Published on: August 16, 2019

8.5K
Efficient Techniques for Comprehensive Sampling of Accessible Tissues in Adult Xenopus
08:36

Efficient Techniques for Comprehensive Sampling of Accessible Tissues in Adult Xenopus

Published on: June 10, 2025

752

Area of Science:

  • Pharmaceutical Sciences
  • Regulatory Affairs
  • Public Health

Background:

  • Import testing is a regulatory process for medicines entering a country.
  • Risks to drug quality and safety are primarily in illegitimate supply chains and domestic trade, not at the point of import.
  • Current international harmonization efforts (e.g., PIC/S, ICH) and adherence to Good Manufacturing Practices (GMPs) and Good Distribution Practices (GDPs) by manufacturers are key.

Purpose of the Study:

  • To critically evaluate the historical and current practices of import testing for medicines.
  • To address misconceptions and concerns regarding the efficacy and necessity of import testing.
  • To advocate for alternative strategies for ensuring drug quality and safety.

Main Methods:

  • Review of historical data and current regulatory practices concerning import testing.
  • Analysis of risk factors within pharmaceutical supply chains.
  • Comparative assessment of import testing versus postmarketing surveillance.

Main Results:

  • Import testing provides negligible value to drug quality and safety when manufacturers comply with GMPs and GDPs.
  • Risks are concentrated in illicit trade and internal distribution, areas not effectively covered by import testing.
  • The trend towards international regulatory harmonization reduces the rationale for redundant import controls.

Conclusions:

  • Import testing is a redundant procedure that does not significantly enhance drug quality or safety.
  • Postmarketing surveillance is a more appropriate and effective method for controlling medicine quality and addressing risks like counterfeits and supply interruptions.
  • Focus should shift from import testing to robust postmarketing surveillance systems and adherence to international standards.