To start the search, start entering the desired term in the search field. Found in the terms and phrases in the dictionary will be shown in the drop-down list (first 30). To obtain more accurate results, continue to enter a phrase or select another search mode.
Depending on the selected search mode, the dictionary is looking for a desired term or from the beginning of each term / phrase, or anywhere in the term / phrase or is looking for its exact compliance. Also for finding a term / phrase you can use the alphabetic pointer from above.
You can choose the term / phrase from the drop-down list to the up / down arrow keys (after selecting to display the dictionary card, press the ENTER key)
On the right there is a column with the last five terms added to the dictionary, as well as the history of your dictionary search (the last ten search queries). The story is stored on your computer and can be deleted at any time (for this click on the "Clear" link)
If you are looking for in mode "Since the beginning of the phrase" And did not find anything, then try switching to mode "Any place phrase".
Word article comprises: the famous term (Displayed at the beginning together with a direct link to the dictionary editing) and translation options. Each transaction option may include: information from canceled term or not as well recommended instead of him, definition This term specified in the source document (is in italics), note to the definition specified in the document or applements of the vocabulary, document's namefrom which the term / phrase and date added to dictionary.
We are constantly refining and replenishing the dictionary. If you have found an error, inaccuracy in the terminology or dictionaries, or want to offer a new feature, please contact us by mail: [Email Protected] .
We hope that the dictionary will help you in daily work. We wish you pleasant use!
The rapid development of the international pharmaceutical industry in 70-80. The 20th century and the globalization of the pharmaceutical market began to slow down by the disassembled national drug registration systems, primarily differences in specifications. Along with this, the rise in the cost of health costs, research work on the creation of new drugs, the need for quick access to the population to modern more efficient drugs demanded the harmonization of regulatory requirements. In 1989, the Paris Conference of Medicinal Regulators, annually held, this issue began to be decided by the regulators of the United States, the EU and Japan. In April 1990, representatives of the agencies of these countries and manufacturers' associations created an international harmonization conference, the secretariat of which is located in Geneva at the headquarters of the International Federation of Pharmaceutical Manufacturers of Associations. (IFPMA). The initial task of ICH was the harmonization of technical requirements for a registration dossier submitted to the EU, USA and Japan. As the conference has been successful, its tasks have been expanded. The main tasks of ICH for the current decade were defined on its 5th conference in San Diego in 2000:- creating a forum for a constructive dialogue between regulatory authorities and the pharmaceutical industry in terms of existing and objective differences in registration requirements in the United States, EU and Japan to ensure faster introduction into the practice of new medical products and access to them; participation in public health with international Prospects; monitoring and updating harmonized technical requirements leading to greater mutual recognition of data on research and development of medicines; the exception in the future of various requirements by harmonizing the selected areas necessary for the further development of therapy and new technologies for the production of medical products; ensuring the dissemination and understanding of harmonized manuals and hiking that update or replace current provisions and allow you to more economically use human and material resources without damage to security; ensuring the distribution and understanding of harmonizer Guidelines, their uses for implementing and combining common standards.
- The European Union of Medical Products (EMEA) and the European Federation of Pharmaceutical Manufacturers and Associations (EFPIA) are participating from the European Union (EMEA) (PhRMA). Agency of Japan in the work on harmonization is involved agency for drugs and medical devices of the Ministry of Health, Labor and Social Affairs of Japan and the National Institute of Health Sciences, as well as the Association of Japanese Pharmaceutical Manufacturers (JPMA).
- safety (Safety)
Document code | Title of management |
Studies on mutagenicity |
|
| S1A. | The need for a study of mutaging drugs |
| S1B. | Check on the mutagenicity of drugs |
| S1C (R1) | Selection of doses for studies of mutaging drugs and dose limit |
| S2A. | Guide to specific aspects of testing of regulatory genotoxicity for preparations |
| S2B. | Gototoxicity: A Standard Battery for Genotoxicity Testing Of Pharmaceuticals |
| S3A | Note to the leadership of Toxicokinetics: Evaluation of the overall exposure in toxicity studies |
| S3B. | Pharmacokinetics: Resection Distribution Guide in Tissues |
Check for toxicity |
|
| S4. | Single dose toxicity tests |
| S4a. | Duration of testing of constant toxicity on animals (toxicity testing on rodents and not rodents) |
Generative toxicology |
|
| S5 (R2) | Detection of toxicity of medical products for reproductiveness and toxicity to reproduction of offspring in men |
| S5A. | Ich Support Toxicity Standards for Men's Fruit |
Biotechnology products |
|
| S6. | Evaluation of the preclinical security of biotechnologically received drugs |
Pharmacology research |
|
| S7A | Studies of safety pharmacology for drugs |
| S7b. | Nonclinic potential assessment for lagging ventricular repolarization (QT intermediate prolongation) drugs for people |
Immunotoxicological studies |
|
| S8. | Immunotoxicological research on medicines for people |
- efficacy (Efficacy)
Safety of clinical studies |
|
| E1 | The number of patients who are subject to a clinical study of the safety of drugs intended for long-term treatment of states of not threatening life |
| E2A | Clinical Security Data Management: Definitions and Standards for Urgent Report |
| E2B (R3) | Clinical Security Data Management: Data Element for Special Case Safety Migration |
| E2C (R1) | Clinical Safety Data Management: Periodic Security Reporting Update For Drug Administration Sale E2C: Periodic Security Reporting Update for Sale Drugs in E2C (R1)) |
| E2D. | Management of security data after the output to the market: definitions and standards for reports |
| E2E. | Planning pharmaconadzora |
Clinical Research Reports |
|
| E3. | Structure and content of clinical research reports |
Research effect depending on the dose |
|
| E4. | Dose Effect Information for making data in registration dossier |
Ethnic factors |
|
| E5 (R1) | Ethnic factors in the acceptability of foreign clinical data |
GCP.(Proper clinical practice) |
|
| E6 (R1) | GCP (proper clinical practice) |
Clinical trials |
|
| E7. | Research in confirmation on specific populations: Geriatry |
| E8. | The main consideration of clinical trials |
| E9. | Statistical principles for clinical trials |
| E10. | Select the control group and related data in clinical trials |
| E11 | Clinical study of medical products for children |
Regulators of clinical evaluation on therapeutic category |
|
| E12. | Principles of clinical assessment of new antihypertensive drugs |
Clinical Evaluation |
|
| E14 | CLINICAL EVALUATION QT / QTC Prolongation interval and pro-amitimical potential for non-nucleic drugs |
Pharmacoenomika |
|
| E15 | Terminology in Pharmacogenomy |
- quality (Quality)
| Document code | Title of management |
Stability |
|
| Q1A (R2) | Stability Testing of New Drug Substances and Products "Test Stability of New Pharmaceutical Substances and Preparations" |
| Q1B. | Stability Testing: PhotoStability Testing of New Drug Substances and Products "Test of photostability of new pharmaceutical substances and drugs" |
| Q1C. | Stability Testing for New Dosage Forms "Test Stability of New Drug Forms" |
| Q1d. | Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products "Grouping methods for testing the stability of new pharmaceutical substances and drugs" |
| Q1E. | Evaluation of Stability Data "Assessment of Stability Data" |
| Q1F. | Stability Data Package for Registration Applications in Climatic Zones III and IV "The amount of stability data for registration dossiers for drugs used in climatic zones III and IV" |
Validation |
|
| Q2 (R1) | New title: Validation of Analytical Procedures: Text and MethodologyPreviously: Text On Validation of Analytical ProceduressName Title: "Validation of analytic techniques: content and methodology" In addition to the guidelines "Content of validation of analytical techniques" and "Validation of analytical techniques: Methodology" |
| Impurities | |
| Q3A (R2) | IMPURITIES IN NEW DRUG Substances "impurities in new pharmaceutical substances" |
| Q3B (R2) | IMPURITIES IN NEW DRUG PRODUCTS "Impurities in new drugs" |
| Q3C (R2) | Impurities: Guideline for Residual Solvents "Impurities: Guide for residual solvents" |
| Pharmacopoeia | |
| Q4. | Pharmacopoeias "Pharmacopoei" |
| Q4A. | Pharmacopoeial Harmonisation "Harmonization of Pharmacopy" |
| Q4B. | Regulatory Acceptance of Analytic Procedures and / or Acceptance Criteria (RAAPAC) "Recognition by regulatory authorities of analytical techniques and / or acceptability criteria" |
| Quality of biotechnology preparations | |
| Q5A (R1) | VIRAL SAFETY EVALUATION OF BIOTECHNOLOGY PRODUCTS DERIED FROM CELL LINES OF HUMAN OR ANIMAL ORIGIN "Evaluation of viral security of biotechnological products obtained from human and animal cell strains" |
| Q5B. | Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of R-DNA DERIED PROTEIN Products "Quality of biotechnological preparations: Analysis of expression gene structures in cells used to produce protein preparations using recombinant DNA" |
| Q5C. | Quality of Biotechnological Products: Stability Testing of Biotechnological / Biological Products "Quality of biotechnological preparations; Evaluation of the stability of biotechnological / biological preparations " |
| Q5d. | DERIVATION AND CHARACTERISATION OF CELL Substrates Used for Production of Biotechnological / Biologic Products "Obtaining and characteristics of cell substrates used in the production of biotechnological / biological preparations" |
| Q5E. | Comparability of Biotechnological / BioLogical Products Subject to Changes In Their Manufacturing Process "Compare (identity) of biotechnological / biological drugs in case of changes in the technological process of their receipt" |
| Specifications | |
| Q6A. | Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances (Including Decision Trees) "Specifications: Quality parameters and an acceptability criteria for new pharmaceutical substances and drugs: Chemical substances (including algorithms)" |
| Q6B. | Specifications: Test Procedures and Acceptance Criteria for Biotechnological / Biological Products "Specifications: Quality parameters and an acceptable criteria for biotechnological / biological preparations" |
| Proper production practice | |
| Q7. | Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients "Guide for Proper Production Practice for Active Pharmaceutical Components" |
| Development of pharmaceutical products | |
| Q8. | Pharmaceutical Development "Development of pharmaceutical products" |
| Quality risks management | |
| Q9. | Quality Risk Management "Risk management related to quality" |
| Q10. | Pharmaceutical Quality System "Quality System at the pharmaceutical enterprise" Stage 3. |
The introduction of uniform standards at the international level is a sufficiently long process, especially if these standards concern complex processes. Nevertheless, the harmonization of regulatory requirements in the pharmaceutical sector at the global level is gaining strength. The root of this trend is the increasing degree of globalization of the pharmaceutical production itself. In addition to improving efficiency, the harmonization of regulatory requirements should eventually provide wide access to high-quality drugs to all those who need them, no matter where they are geographically
Today, the harmonization process is still far from an acceptable level. This leads to a significant loss of time and funds in the pharmaceutical industry. For example, according to the data given in the review of the European Federation of Pharmaceutical Enterprises and Associations (European Federation of Pharmaceutical Industries and Associations - EFPIA), in some cases, the cost of preparing a new drug may be 15-20% of the cost of clinical trials, in which There are hundreds of millions of dollars. The study showed that there are a large number of inspection organizations, partly unnecessary, which require hundreds of thousands of dollars for their existence. After all, the inspection of one production is spent from 1000 to 2500 people-hours. Harmonization of approaches to the preparation of a dossier, the introduction of unified production inspection standards would help avoid unnecessary costs in the pharmaceutical sector as a whole and send saved resources to solve the necessary tasks. (Europe today)
Significant results were achieved over the past five years in the standardization of requirements for R & D and clinical trials, as well as the harmonization of regulatory requirements for finished dosage forms, active pharmaceutical ingredients (AFI) and auxiliary substances.
The main driving force of the process of harmonization of regulation in the pharmaceutical sector is the International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceutical Preparesses used by the person (ICH International Conference on Harmonization. For the past 21 years, the activities of the ICC are aimed at eliminating excessive documentation and simplify the development process, production and registration of pharmaceutical preparations. Ich consists of representatives of regulators, pharmacopy and drug producers from the USA, Japan and Europe. Forces of this organization, a general approach to the problem of harmonization was developed and priorities are placed to implement this complex and multilateral project.
In addition to ICH, a number of other organizations are engaged in the harmonization of regulatory requirements in the pharmaceutical sector, such as USA's Pharmacopeias Discussion Group). The World Health Organization (World Health Organization) is also involved in the harmonization process, as well as the All-American Society for Harmonizing Regulation in the field of drugs. Other groups involved in the harmonization of regulatory requirements in various countries concentrated their efforts on individual problems in the field of active pharmaceutical ingredients and auxiliary substances.
Some successes in the field of harmonization
As an example, the progress made by the United States and European countries to harmonize regulatory requirements in the pharmaceutical sectors of these countries can be brought. Applying ICH recommendations relative to quality standards and using the general format of technical documentation, the United States and Europe entered a single form of a dossier for a number of drugs.
Japan, who moved back on the path of national standards for five years ago, is now exhibiting a significant interest in cooperation in the direction of harmonizing regulatory requirements in the pharmaceutics.
Perhaps the most significant symbol of progress in the field of harmonization achieved in the 21st century is a single electronic form of technical documentation, which companies are used to prepare a registration dossier. As a joke now recall the time when to deliver the entire volume of registration file documents to regulators it was necessary to take a truck.
In the field of harmonization of the standards for the production of pharmaceuticals, the process passing at present is the direct reflection of the realities of the supply of most of the AFIs in the United States and the countries of Europe from India and China. Two years ago Food and Drug Administration (Food and Drug Administration -) and USA (USP) opened offices in China, India and Latin America. The presence of representative offices and USP directly in the manufacturing countries made it possible to improve their interaction with local regulators, manufacturers and pharmacists.
Progress in the field of harmonization of pharmacopy, AFI and auxiliary substances
The harmonization of pharmacopy began about 10 years ago. Over time, it was possible to establish good cooperation between US Pharmacops, Japan and Europe. However, the harmonization in this area is a long and extremely laborious process. For example, the US patent documentation group (USP's PDG) has been worked out until now only 27 of the 34 general provisions and 40 of 63 monographs on the agencies.
Attempts are being made to harmonize monographs up to prepared drugs.
At the global level, one of the key points is the harmonization of the quality parameters of the AFI and auxiliary substances. It is planned that the United States will contain monographs on all pharmaceutical agencies according to the list. At the same time, the International Working Group on the Dissemination of Excellence will be created. European Directorate for the Quality of Medicines & Healthcare - EDQM) installed bilateral connections with the FDA USA and a similar Australian Agency
(Australia's Therapeutic Goods Administration - TGA) for the exchange of confidential information on AFI and the auxiliary substances. As part of these agreements, as a pilot project, mutual inspections began last year.
For harmonization at the global level of the parameters of the quality of the aids, several possibilities are considered. One of them is the application of requirements for the production of auxiliary substances; Another is the participation of manufacturers in the Voluntary Inspectorate Program of Independent Auditors. INTERNATIONAL PHARMACEUTICAL EXCIPIENTS AUDITING ASSOCIATION AUDITORS OF AUDTIVITY AUDTIVITIES AUDTICAL EXCIPIENTS AUDITING (INTERNATIONAL PHARMACEUTICAL EXCIPIENTS AUDITING) is registered in the American National Institute of Standards, which will allow it to fulfill the function of an independent auditor of quality.
Remaining differences
Harmonization does not mean a literal repetition of all pharmaceutical registration procedures. There will always be differences in the approaches used by different regulatory departments. Even in the framework of one European Union, a new one can register "centralized", i.e. Through the EU bodies, or go through registration in national agencies. The US FDA strategy is to harmonize the requirements for the safety of pharmaceuticals in the United States and the EU, although some differences in approaches and procedures will still remain.
National specificity is visible on the example of the inspection of pharmaceutical production. FDA USA, for example, focuses on the investigation of cases of deviation from the norm, the rules for the validation, content and purity of equipment and industrial premises. In the EU countries, the main efforts are aimed at compliance with the purity of the premises and their classification, the maintenance of equipment and laboratory control. In Japan, the inspector placed increased requirements for the quality of raw materials, cleanliness of production equipment and the appearance of ready-made pharmaceuticals.
"Pharmaceutical Industry", April №2 (19) 2010
Content Pages
The Eurasian Economic Commission has developed a draft rules for conducting research of biological drugs in the territory of the Eurasian Economic Union (EAEU). The purpose of the document is to simplify the collection and provision of data attached to applications for the registration of biological drugs.
The rules are necessary for the formation of a common medicine market in the EAEU, which will start working from January 1, 2016. With this date, safe, efficient and high-quality drugs will be able to move freely throughout the union.
The draft Rules was developed on the basis of the provisions set out in the relevant documents of the International Conference on Harmonying Technical Requirements for Drug Registration (ICH) and the European Medical Agency (EMA).
The document regulates the development, safety, safety, efficiency and quality studies of both new biological drug molecules and biopoid drugs. At the same time, there are chapters in the rules concerning general research issues: from banks producing cells to prepared drugs. There is a separate chapter that contains preparation-specific requirements for the development, production and research of biopoid drugs.
A clear following rules will help pharmaceutors perform a full cycle of studying biological products, confirm their safety, quality and efficiency, ensuring that biomolecules reproduced by their prototypes. This will allow replacing drugs with their comparable safety and efficiency.
It should be noted that the rules are mandatory for authorized bodies and expert organizations in the implementation of the examination of the safety, quality and effectiveness of this group of drugs in the process of assessing their registration files.
The high degree of harmonization of the rules with the requirements of the relevant international documents will facilitate the process of the release of these drugs to foreign markets, will contribute to the recognition of data on pharmaceutical development and the results of confirmation of security, quality and efficiency when they are registered outside the Union.
The draft decision of the Council of the ECE on the approval of the Rules for conducting biological drugs on the territory of the Eurasian Economic Union is published on the Sites of the Eurasian Economic Union in the section "Public Discussions and ODS" and the Eurasian Economic Commission on the page of the Technical Regulation and Accreditation Department of the ECE in the "Public Discussion of Regulatory Projects legal acts. "
All interested parties can provide comments on the Technical Regulation and Accreditation Department of the ECE within 30 days from the date of publication of the draft document.
reference
TO biological drugs Immunobiological and biotechnological drugs, drug preparations derived from human blood plasma, probiotics preparations (eubiotics), bacteriophage preparations, high-tech drugs.
International Conference on Harmonization of Technical Requirements for Drug Registration (ICH) - an organization uniting regulatory authorities and the pharmaceutical industry in Europe, Japan and the United States to discuss scientific and technical aspects of drug registration.
European Medical Agency (EMA) - Agency of the European Union, which is responsible for the scientific assessment of drugs developed by pharmaceutical companies for use in the EU.
Water heater Country Evbo 15 1
Punctuation analysis of the sentence: easy and simple
What did Kulibin invented? (8 photos). Kulibin - the most famous Russian inventor from where the Kulibin
Resurrection of righteous lasquary
What was invented by Kulibin I. P.: The most famous creations of a talented master. Kulibin - the most famous Russian inventor and P Kulibin brief biography