What are the processes that a new drug needs to go through from R D to marketing?

According to the regulations of the US FDA, a new drug must go through a total of 4 phases of clinical trials from R&D, marketing to promotion and application, and must pass the first 3 phases before being marketed.

The role and pass rate of each phase of clinical trials are different, and as long as any of the three phases fails, the road to marketing will be forced to be suspended. Only through the next step of the listing process.

Phase 1 clinical trials, which usually last several months and are designed to test the safety of the drug, are relatively easy to pass, with a pass rate of up to 70%.

Phase 2 clinical trials: Phase 2 clinical trials can be divided into two phases, 2a and phase 2 are just a small range to test the effective dose of the drug. Once this is determined, a clinical trial of the drug's effectiveness is conducted.

The duration varies from a few months to 2 years. At this stage, the pass rate has plummeted, and only 33% of new drugs can be successfully passed.

Phase 3 clinical trial: up to 1-4 years, the main task of this phase is to collect more information on safety and efficacy, and to study the compatibility of the new drug with other drugs in different populations, different doses, and other drugs. The pass rate of phase 3 clinical trials is only 25%-30%, which is a "roadblock" for many new drugs to be launched.

Phase 4 clinical trial: Phase 4 clinical trial is a continuous study of the safety and efficacy of a new drug after it is marketed, because the *** of some new drugs may not appear until several years later, so it is necessary to continue to follow up after marketing to avoid future troubles.

AbstractHello, it takes about 15 years for a new drug to be developed from phase III clinical trial to marketing. First of all, it takes 2 to 3 years for the research and development of drugs, 2 to 3 years for preclinical experiments, several years for phase I clinical trials, and 3 to 7 years for clinical experimental drugs. It is necessary to ensure various safety standards before it can be marketed, so it will be about 15 years.

How long does it take for a new drug to go from phase III clinical trial to launch?

Hello, it takes about 15 years for a new drug to be developed from phase III clinical trial to marketing. First of all, it takes 2 to 3 years for the research and development of drugs, 2 to 3 years for preclinical experiments, several years for phase I clinical trials, and 3 to 7 years for clinical experimental drugs. It is necessary to ensure various safety standards before it can be marketed, so it will be about 15 years.

Hope it can help you, thank you, dear.

I mean, the clinical trial has entered the third phase, and how many years will it take to go from the third phase to the market?

Oh, and that depends on efficiency. If it starts from the phase III clinical stage, it should take about 3 to 7 years.

There are many phases, and how long it depends on the progress of the experiment.

R&D (generally 2-3 years).

Laboratory studies to find potential new compounds for specific diseases.

1) Discovery and confirmation of drug targets.

This is the starting point of all work, and only when the target is determined, all subsequent work has the basis.

2) Screening and synthesis of compounds.

According to the spatial structure of the target, a series of matched molecular structures are screened from a virtual compound library to synthesize these compounds, which are called lead compounds.

3) Validation and optimization of active compounds.

Not all lead compounds can meet the requirements, and at this stage, it is necessary to verify through in vitro cell assays, preliminarily screen out compounds with high activity and low toxicity, and optimize their structures according to the structure-activity relationship, these compounds are called drug candidates.

Features:

In terms of the object of use: it is the object of human use, prevention, and diagnosis of human diseases. Purposefully regulate human physiological functions, with prescribed indications, usage and dosage requirements; In terms of usage:

Beyond the appearance, the patient cannot recognize its intrinsic quality, and many medicines need to be used under the guidance of a doctor, not by the patient's choice.

At the same time, the use of drugs, quantity, time and other factors determine the use effect to a large extent, misuse not only can not "cure", but also may "cause disease", and even endanger life safety. Therefore, medicine is a special commodity.

1.The reporting unit fills in the application form for clinical research (or production) of new drugs, and submits it to the drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government together with the declared technical information and samples. The provincial drug regulatory department conducts a preliminary review, that is, to review whether the original materials of the new drug are complete; At the same time, send personnel to conduct on-site inspections on the trial production conditions and fill in the inspection report form

2.The drug inspection institutes of provinces, autonomous regions and municipalities directly under the Central Government shall complete the review of the application materials and the inspection of samples in accordance with the technical requirements for the approval of new drugs. The review of the drug control institute refers to the review of the pharmaceutical (including pharmacology and toxicology) research data of the new drug and the experimental testing of the samples; It does not include research on new testing methods for the reporting unit.

3.If the provincial drug supervision and management department passes the preliminary review and reports to the same dispersion, the application form for clinical research (or production) of the new drug shall be signed, and 5 copies of the declared technical information shall be submitted to the Registration Department of the State Drug Administration for formal review.

4.If the Registration Department of the State Drug Administration passes the formal examination, it will issue a notice to the applicant to collect the review fee. At the same time, it will be submitted to the Center for Drug Evaluation to arrange technical review, review by the review committee and necessary review. If the formal examination is unqualified, it shall be withdrawn from the examination.

5. After the technical review is passed, the review report and opinions recommended for approval or withdrawn shall be submitted to the Drug Registration Department of the State Drug Administration. Handle the approval of the application for clinical research of new drugs, and submit it to the director of the Registration Department of the State Drug Administration for approval. After obtaining the approval of clinical research, the applicant shall conduct clinical trials of new drugs in the selected clinical research responsible and undertaking units.

6. Handle the approval of the new drug production application, submit it to the director of the registration department for review, and then forward it to the director of the State Drug Administration for approval. The National Pharmacopoeia Commission is responsible for the review of new drug quality standards and conversion technology. Send the application approval document to the reporting unit, etc.

Extended Information: Preclinical Studies.

1.Confirmation of drug targets.

This is where all the work begins. Only when the target is determined, all subsequent work can be based.

2.Synthesis of compounds.

This stage of work is mainly responsible for the synthesis of new compounds, structural modification and optimization of existing compounds.

3.Screening of active compounds.

Not all synthesized compounds can have ideal activity, and it is necessary to screen out the preliminarily active compounds as candidates through biological experiments at this stage. This step is mainly at the level of cell experiments.

1. Drug discovery

1.Selection and confirmation of drug targets and biomarkers.

2.Determination of lead compounds.

3.Study of structure-activity relationship and screening of active compounds.

4.Selection of drug candidates-candidates.

2. New drug R&D stage - development

1.ChemicalManufacture and Control (CMC).

2.Pharmacokinetics.

pharmacokinetics, pk)

3.Safety pharmacology

4.Toxicology

5.Formulation development.

3. Human trial stage of new drugs.

Phase 1 clinical trial.

Phase 2 clinical trials.

Phase 3 clinical trials.

Finally, data were analyzed according to rigorous statistical data.

Further evaluate the efficacy and tolerability (or safety) of the drug, and decide whether the new drug is superior or not inferior to the existing "old drug" in the market. Old.

Phase clinical trial is the most conclusive stage of the first effect, and it is also the key stage to provide the basis for the approval of the drug registration application, which is the busiest and most concentrated part of the clinical research project, and is undoubtedly the most important step in the entire clinical trial. Phase 3 clinical studies tend to last several years.

4. New drug application.

After all three phases of clinical trials are completed and all data and data are analyzed, the safety and efficacy of the drug has been demonstrated, and the new drug holder can submit a new drug application to the FDA (C) FDA.

The new drug application needs to provide all scientific information collected. Usually a new drug application can be as long as 100,000 pages, or even more! According to the regulations, the FDA should review it within 6 months.

Complete the evaluation of the new drug application. However, due to the large number of application materials and many irregularities, it can often be completed in such a short time. The China Food and Drug Administration is also working to improve its work and expects to shorten the approval time.

5. New drugs are approved for marketing.

Once the new drug application is approved by the Ministry of Food and Drug Administration, the new drug can be officially marketed for doctors and patients to choose. However, the holder of the new drug must also submit relevant information to the drug regulatory authority on a regular basis, including the *** of the drug.

Situation and quality management.

Recording. For some drugs, the drug regulatory department will also require a phase IV clinical trial to observe its long-term clinical trial.

If we can get this far, then we can say that we are done for the time being.

6. Phase IV clinical study (post-marketing surveillance).

After the drug is used in a wide range of people, it needs to have its efficacy and adverse reactions.

Monitoring continues. The drug regulatory authority requires that the drug instructions be revised based on the results of monitoring at this stage.

Legal analysis: According to the current drug registration management measures and related policies, and depending on the type of review, it is generally about 180 to 240 working days (about one to one and a half years to a year and a half) to complete the review and issue the drug marketing authorization in China, from the date when the new drug marketing application and related materials are delivered to the evaluation center of the State Food and Drug Administration and the acceptance notice is obtained. A license here refers to a license that allows the traveler to produce and sell medicines.

Permission here means that the licensee can produce and sell the drug. As for the drug being available in the market or being prescribed in the hospital, it depends on the level of the pharmaceutical company's marketing sales team, which on average takes about 3 to 6 months.

Legal basis: Drug Administration Law of the People's Republic of China

Article 24 Drugs marketed in China shall be approved by the drug regulatory department and obtain a drug registration certificate; However, Chinese herbal medicines and Chinese herbal decoction pieces that have not been subject to approval management are excluded. The catalogue of varieties of Chinese herbal medicines and Chinese herbal decoction pieces that are subject to approval and management shall be formulated by the drug regulatory department in conjunction with the competent department of traditional Chinese medicine. To apply for drug registration, true, sufficient and reliable data, materials and samples shall be provided to prove the safety, effectiveness and quality controllability of the drug.

Article 25 For the drugs applied for registration, the drug regulatory department shall organize pharmaceutical and medical and other technical personnel to conduct a review to review the safety, effectiveness and quality controllability of the drug, as well as the applicant's ability of quality management, risk prevention and control, and liability compensation; If the conditions are met, a drug registration certificate will be issued. When approving drugs, the drug regulatory department shall review and approve the chemical raw materials, the relevant excipients, packaging materials and containers in direct contact with the drug, and the quality standards, production processes, labels and instructions of the drugs. The term "excipients" in this Law refers to the excipients and additives used in the production of drugs and the preparation of prescriptions.