Высокотехнологические (ЛП)

English translation: advanced therapy medicinal product (ATMP)

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
Russian term or phrase:высокотехнологический лекарственный препарат
English translation:advanced therapy medicinal product (ATMP)
Entered by: Peter Shortall

18:59 Jan 24, 2021
Russian to English translations [PRO]
Medical - Medical: Pharmaceuticals / Материалы регистрационного досье по качеству лекарственных средств
Russian term or phrase: Высокотехнологические (ЛП)
Орфанные препараты (препараты, предназначенные для лечения редких заболеваний).
...
Высокотехнологические лекарственные препараты.

TIA!
Yuri Larin
Ukraine
Local time: 11:26
advanced therapy medicinal products (ATMPs)
Explanation:
Я вот такой термин встречал в практике.

По аналогии с положениями директивы, приложение № 1 к Правилам регистрации и экспертизы содержит часть IV, озаглавленную как «Высокотехнологичные лекарственные препараты». Именно так было решено перевести европейский термин «лекарственные препараты передовой терапии» (advanced therapy medicinal products).
https://cyberleninka.ru/article/n/problemy-regulirovaniya-ra...

Сравните следующие определения:

1) высокотехнологический лекарственный препарат – лекарственный препарат, являющийся **генотерапевтическим** лекарственным препаратом, лекарственным препаратом на основе **соматических клеток** или препаратом **тканевой инженерии**;
https://www.ndda.kz/upload/dari.kz/KTP/736_expertise.pdf

Advanced therapy medicinal products (ATMPs) are medicines for human use that are based on genes, tissues or cells. They offer groundbreaking new opportunities for the treatment of disease and injury.

ATMPs can be classified into three main types:

**gene therapy** medicines: these contain genes that lead to a therapeutic, prophylactic or diagnostic effect. They work by inserting 'recombinant' genes into the body, usually to treat a variety of diseases, including genetic disorders, cancer or long-term diseases. A recombinant gene is a stretch of DNA that is created in the laboratory, bringing together DNA from different sources;
**somatic-cell therapy** medicines: these contain cells or tissues that have been manipulated to change their biological characteristics or cells or tissues not intended to be used for the same essential functions in the body. They can be used to cure, diagnose or prevent diseases;
**tissue-engineered medicines**: these contain cells or tissues that have been modified so they can be used to repair, regenerate or replace human tissue;
https://www.ema.europa.eu/en/human-regulatory/overview/advan...

IV. Высокотехнологические лекарственные препараты

17.1. Введение
17.2. Определения
17.2.1. **Генотерапевтические** лекарственные препараты
17.2.2. Лекарственные препараты на основе **соматических клеток**
17.3. Специальные требования к модулю 3 регистрационного досье
17.3.1. Специальные требования для всех высокотехнологических лекарственных препаратов
17.3.2. Специальные требования к **генотерапевтическим** лекарственным препаратам
17.3.3. Специальные требования к **соматотерапевтическим** лекарственным препаратам и препаратам **тканевой инженерии**
http://www.consultant.ru/document/cons_doc_LAW_207379/
Selected response from:

Peter Shortall
United Kingdom
Grading comment
Thanks, Peter and Frank!
4 KudoZ points were awarded for this answer



Summary of answers provided
3 +3high-technology medicinal products
Frank Szmulowicz, Ph. D.
4advanced therapy medicinal products (ATMPs)
Peter Shortall


  

Answers


4 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +3
high-technology medicinal products


Explanation:
Council of the European Communities Directive 93/41/EEC of 14 June 1993 repealed Directive 87/22/EEC on the approximation of national measures relating to the marketing of high-technology medicinal products, as this directive had been superseded by Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (5) and by Council Directive 88/182/EEC of 22 March 1988 amending Directive 83/189/EEC laying down a procedure for the provision of information in the field of technical standards and regulations (6).
https://en.wikipedia.org/wiki/Directive_93/41/EEC

Frank Szmulowicz, Ph. D.
United States
Local time: 05:26
Works in field
Native speaker of: Native in EnglishEnglish, Native in PolishPolish
PRO pts in category: 282

Peer comments on this answer (and responses from the answerer)
agree  Oleg Lozinskiy
16 mins
  -> Thank you, Oleg. Take care!

agree  Turdimurod Rakhmanov
17 mins
  -> Thank you, Turdimurod. Have a good week ahead!

agree  Ravindra Godbole
7 hrs
  -> Thank you, Ravindra. All the best!
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48 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5
advanced therapy medicinal products (ATMPs)


Explanation:
Я вот такой термин встречал в практике.

По аналогии с положениями директивы, приложение № 1 к Правилам регистрации и экспертизы содержит часть IV, озаглавленную как «Высокотехнологичные лекарственные препараты». Именно так было решено перевести европейский термин «лекарственные препараты передовой терапии» (advanced therapy medicinal products).
https://cyberleninka.ru/article/n/problemy-regulirovaniya-ra...

Сравните следующие определения:

1) высокотехнологический лекарственный препарат – лекарственный препарат, являющийся **генотерапевтическим** лекарственным препаратом, лекарственным препаратом на основе **соматических клеток** или препаратом **тканевой инженерии**;
https://www.ndda.kz/upload/dari.kz/KTP/736_expertise.pdf

Advanced therapy medicinal products (ATMPs) are medicines for human use that are based on genes, tissues or cells. They offer groundbreaking new opportunities for the treatment of disease and injury.

ATMPs can be classified into three main types:

**gene therapy** medicines: these contain genes that lead to a therapeutic, prophylactic or diagnostic effect. They work by inserting 'recombinant' genes into the body, usually to treat a variety of diseases, including genetic disorders, cancer or long-term diseases. A recombinant gene is a stretch of DNA that is created in the laboratory, bringing together DNA from different sources;
**somatic-cell therapy** medicines: these contain cells or tissues that have been manipulated to change their biological characteristics or cells or tissues not intended to be used for the same essential functions in the body. They can be used to cure, diagnose or prevent diseases;
**tissue-engineered medicines**: these contain cells or tissues that have been modified so they can be used to repair, regenerate or replace human tissue;
https://www.ema.europa.eu/en/human-regulatory/overview/advan...

IV. Высокотехнологические лекарственные препараты

17.1. Введение
17.2. Определения
17.2.1. **Генотерапевтические** лекарственные препараты
17.2.2. Лекарственные препараты на основе **соматических клеток**
17.3. Специальные требования к модулю 3 регистрационного досье
17.3.1. Специальные требования для всех высокотехнологических лекарственных препаратов
17.3.2. Специальные требования к **генотерапевтическим** лекарственным препаратам
17.3.3. Специальные требования к **соматотерапевтическим** лекарственным препаратам и препаратам **тканевой инженерии**
http://www.consultant.ru/document/cons_doc_LAW_207379/

Peter Shortall
United Kingdom
Works in field
Native speaker of: English
PRO pts in category: 4
Grading comment
Thanks, Peter and Frank!
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