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Translational Regulation

Translational Regulation

Translational regulation in prokaryotes ensures efficient protein synthesis by controlling ribosome access to mRNA. This regulation is mediated by secondary RNA structures, including translational riboswitches, RNA thermometers, and small RNAs (sRNAs), which respond to intracellular and environmental signals to modulate gene expression.Translational RiboswitchesRiboswitches in the leader region of mRNAs can regulate translation by altering the accessibility of the Shine-Dalgarno (SD) sequence,...

Regulation of Expression at Multiple Steps

Regulation of Expression at Multiple Steps

The gene expression in cells is regulated at different stages: (i) transcription, (ii) RNA processing, (iii) RNA localization, and (iv) translation. Transcriptional regulation is mediated by regulatory proteins such as transcription factors, activators, or repressors—these control gene expression by initiating or inhibiting the transcription of genes. Once a precursor or pre-mRNA is produced, it undergoes post-transcriptional modification, including 5' capping, splicing, and the addition of a...

Regulation of Expression Occurs at Multiple Steps

Regulation of Expression Occurs at Multiple Steps

Gene expression can be regulated at almost every step from gene to protein. Transcription is the step that is most commonly regulated. This involves the binding of proteins to short regulatory sequences on the DNA. This association can either promote or inhibit the transcription of a gene associated with the respective sequence.
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Types of RNA

Types of RNA

Three main types of RNA are involved in protein synthesis: messenger RNA (mRNA), transfer RNA (tRNA), and ribosomal RNA (rRNA). These RNAs perform diverse functions and can be broadly classified as protein-coding or non-coding RNA. Non-coding RNAs play important roles in regulating gene expression in response to developmental and environmental changes. Non-coding RNAs in prokaryotes can be manipulated to develop more effective antibacterial drugs for human or animal use.
RNA Performs Diverse...

Types of RNA

Types of RNA

Overview
Three main types of RNA are involved in protein synthesis: messenger RNA (mRNA), transfer RNA (tRNA), and ribosomal RNA (rRNA). These RNAs perform diverse functions and can be broadly classified as protein-coding or non-coding RNA. Non-coding RNAs play important roles in the regulation of gene expression in response to developmental and environmental changes. Non-coding RNAs in prokaryotes can be manipulated to develop more effective antibacterial drugs for human or animal use.
RNA...

Ribosome Profiling

Ribosome Profiling

Ribosome profiling or ribo-sequencing is a deep sequencing technique that produces a snapshot of active translation in a cell. It selectively sequences the mRNAs protected by ribosomes to get an insight into a cell’s translation landscape at any given point in time.
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Ribosome profiling has many applications, including in vivo monitoring of translation inside a particular organ or tissue type and quantifying new protein synthesis levels.
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Related Experiment Video

Updated: May 15, 2026

High-throughput Screening for Chemical Modulators of Post-transcriptionally Regulated Genes

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Decoding RNA regulation: Challenges and opportunities for RNA-based therapies in Europe.

Olivia C Lewis¹, Christine Leopold¹, Joyce M Hoek¹

¹Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Faculty of Science, Utrecht University, the Netherlands.

British Journal of Clinical Pharmacology

|May 14, 2026

Summary

Regulatory uncertainty challenges RNA therapeutics in the EU. This study analyzed RNA-drug characteristics to propose a classification framework, aiding regulatory clarity and development for personalized medicine.

Keywords:

RNA regulatory definitions RNA regulatory framework RNA safety concerns RNA therapeutics RNA‐based medicinal products marketing authorisation EU regulatory classification

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Last Updated: May 15, 2026

High-throughput Screening for Chemical Modulators of Post-transcriptionally Regulated Genes

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Published on: March 3, 2015

Cell Based Assays of SINEUP Non-coding RNAs That Can Specifically Enhance mRNA Translation

Cell Based Assays of SINEUP Non-coding RNAs That Can Specifically Enhance mRNA Translation

Published on: February 1, 2019

Area of Science:

Pharmacology
Biotechnology
Regulatory Science

Background:

RNA-based therapeutics offer precise, sequence-specific disease targeting for personalized medicine.
Clinical translation in the EU faces regulatory hurdles due to unclear definitions and evidence standards.
A classification framework is needed to enhance regulatory clarity and support product development.

Purpose of the Study:

To identify commonalities and differences in scientific and clinical characteristics of RNA therapeutics assessed by the European Medicines Agency (EMA).
To inform a classification framework for RNA-based medicines to support regulatory clarity and product development.
To analyze RNA therapeutics for non-infectious diseases seeking EU marketing authorization.

Main Methods:

Qualitative document analysis of 13 RNA-based therapeutics applying for EU marketing authorization by March 2025.
Analysis of regulatory documents (European Public Assessment Reports, Risk Management Plans) for descriptive, scientific, and clinical characteristics.
Data extraction validated through a dual-review process.

Main Results:

Ten of 13 products (siRNAs, antisense oligonucleotides, aptamer) were approved, targeting primarily rare and liver diseases.
Most products function via sequence-specific hybridization to suppress or modify protein production.
Clinical challenges included limited efficacy data and safety concerns (e.g., coagulation risks for ASOs); risk profiles were inconsistently linked to targets or RNA sequence.

Conclusions:

Classification based on RNA mechanism and chemical modifications can align regulatory implications.
A structured framework can facilitate knowledge pooling, particularly beneficial for rare disease indications.
This approach supports regulatory clarity and advances the development of RNA-based medicines.