The cases which are not provided registration numbers when evaluating Drug Registration dossiers in VietNam
According to Document No. 21 501 / QLD-DK December 10, 2014 on guidelines for the evaluation of drug registration dossiers. The Ministry of Health (Drug Administration) regulations:
I/ The case without registration number records after first evaluation includes:
1. The general regulation
1.1. Data is not honest, not derived from the research, formulas development , copy the information.
1.2. Poorly prepared Documents, incomplete sections, arranged messy, sloppy, do not follow the instructions or missing records prescribed records RFA / ACTR.
2. Legal subcommittee
2.1. Registration form:
2.1.1. Dosage form / formula / content inconsistent with the CPP or FSC or other parts of the dossier (manufacturing process, stability, BA / BE ...).
2.1.2. Forging signatures and seal of the company registration and production company.
2.2. Certificates CPP, FSC, GMP
2.2.1. Legality is not guaranteed: information on the grant date is invalid; erase; granted ultra vires; or non-compliance with regulations, as follows:
- No name, address, manufacturer, or there, but not right for your application.
- No dosage forms; no active ingredient formulations, adjuvants.
- There is no date, month, year or have signed but not valid.
2.2.2. In the form of loan production license (license loan).
2.2.3. CPP, FSC / GMP no drug dosage forms of registration; no minimum standards GMP-WHO; FSC does not have the ingredients and concentration of the active ingredient content of the drug; CPP / FSC no or excipient ingredients other than the registered drugs.
2.3. Product information:
2.3.1. The errors related to the nature of the drug (active ingredient, active ingredient content, dosage form).
. Quality Subcommittee:
3.1. Finished product testing certificates:
3.1.1. Testing certificates have not reached the target.
3.1.2. The norms and standards in the testing certificates are inconsistent with the standards of registration.
3.1.3. Testing certificates are inconsistent with the drug samples, materials for drug circulation registration.
3.1.4. Signature, seal testing certificates are not on the manufacturer's testing facility or factory lots.
3.2. Finished products standards, testing methods.
3.2.1. Incomplete standard , lacking of the basic criteria for each dosage form prescribed in the Pharmacopoeia.
3.2.2.Registration standards follows the pharmacopoeia but in fact do not have them in the pharmacopoeia.
3.2.3. Methods of testing: impossible; nonspecific; there is evidence that has not been fully verified before applying.
3.3. Standard of packaging:
3.3.1. Lack of basic standards or manufacturer standards.
3.4. Evaluating methods of analysis:
3.4.1. No evaluated records analytical methods.
3.4.2. Raw data is not correct, does not match the data processing section in the evaluation records.
3.4.3. There is evidence of copying, dishonest.
3.4.4. The appraisal process analysis method is not consistent with the standards and testing methods.
3.5. Active substance:
3.5.1. Standard registration is under the pharmacopoeia,but in real do not have them in the pharmacopoeia.
3.5.2. Unspecifying clearly the impurities configuration or controlling impurities in standards is not suitable with impurities configuration.
3.5.3. Standard lacks important criteria, testing methods are not feasible, nonspecific.
4. Subcommittee preparation, stability:
4.1. The entire technical profile:
4.1.1. There is evidence of copying records, dishonesty.
4.2. Registration form:
4.2.1. Dosage / ingredient recipe / content of active ingredients, excipients inconsistency between an application with the contents of the dossiers and drug samples.
4.3. Drug samples:
4.3.1. Improper drug samples by the manufacturer.
4.3.2. Contravention with samples described in the dossier.
4.3.3. Storage conditions nameplate data is inconsistent with the stability studies (P8).
4.4. Substance (S):
4.4.1. Information about the manufacturer or other drugs shipped batches with research profile stability / drug testing certificates.
4.4.2. Drug name, drug salts of the research profile of stability, record drug quality standards other than the registration and CPP.
4.4.3. The information in section S is not about drugs (derivatives, salts ...), semi-finished products (pellet, grain compact, ready-mixed mixture ...) used in P.
4.4.4. The targets of the research results are not consistent stability with drug registration standards.
4.5. Description and composition (P1):
4.5.1. The formulation is inconsistent with the CPP and the other components of the dossier.
4.6. Product development (P2):
4.6.1. The information in the profile is not consistent with the results of the product development process in the P2 (such as dosage formulations, manufacturing processes, quality standards, stability ...).
4.7. The production process (P3.1, P3.2):
4.7.1 Formula production batches incorrectly.
4.7.2. The production process is not feasible.
4.7.3. Production lot size does not fit in modern equipment.
4.7.4. Description missing / wrong key production stages. Data inconsistency between sections (overview, diagrams, descriptions, ...).
4.8. Control of the production process (P3.3):
4.8.1. Lack of control over critical stages in the manufacturing process that the critical stage has not been fully verified during the evaluation process of production.
4.9. Appraisal process (P3.4):
4.9.1. No records evaluation production processes (both outline and data evaluation).
4.9.2. Content outline and evaluation is inconsistent with the production process.
4.9.3. No appraisal stages, key quality indicators.
4.10. Test excipients (P4):
4.10.1. Excipients in the P4 is not the kind used in the P3.
4.10.2. Excipient standards not found in the document is recorded (as Pharmacopoeia, if any).
4:11. Packaging system (P7):
4.11.1. Packaging is inconsistent with dosage forms.
4.11.2. Packaging other than packaging used in the P2, P3 and P8.
4.12.1. No proposal or research proposal inappropriate (such as storage conditions do not match, do not evaluate the quality criteria indicating stability ...).
4.12.2. There is evidence of dishonest data (time tracking mismatch stability for shelf registration time or allowed to buy or import narcotic raw materials, drugs psychotropic substances used as to produce the study drug).
4.12.3. Equipment stability studies are not consistent with registered dosage forms.
4.12.4. Do track stability is not under research protocols, lack of critical targets at risk change or reduce drug quality during storage.
4.12.5. Research results have indicators of stability are unsatisfactory.
5. Subcommittee pharmacology, clinical.
5.1.1. The contents of the documents in the dossier sent by the nature of the drug.
5.1.2. Dosage / content inconsistent with the dosage.
5.2.1. New drug clinical studies or clinical studies unregulated or can not provide documented formal clinical studies have been recognized.
5.2.2. Coordinate components, drug content, drug designated unfounded and there is no proven scientific literature.
6. Subcommittee bioequivalence.
6.1.1. Profile copying signs, dishonest, there is a conflict, not the logic of data between parts / items in the order of study or in the contents of the report.
6.1.2. Profile is too vague and not enough from the main part as prescribed.
6.2. Research institutions:
6.2.1. There is evidence that providing untruthful information.
6.2.2. Fails to provide legal documents as prescribed.
6.3. Study drug:
6.3.1. Information about medications used in the study sample did not match the registered drugs and / or without appropriate explanation.
6.4. Drug control:
6.4.1. Does not meet the provisions of the drug control selection without explanation or documentation proving persuasive.
6.4.2. No explanation or provide convincing evidence to have the facility to accept controlled drugs.
6.5. Research proposal and approved by the ethics council.
6.5.1. Outline inconsistent with research and / or explanations are not satisfactory, inappropriate.
6.6. Analytical methods:
6.6.1. There is evidence that inappropriate methods or data offer no inconsistant and the proposed data is not correct.
6.7. Results of statistical analysis:
6.7.1. Results calculated incorrectly or not at a level similar drugs as a general rule.
6.8. The original data (clinical records, chromatogram ...).
6.8.1. The original data is not consistent with the results in the synthesis report or research process, data repair in contravention of regulations, signs dishonest.
6.9. Research results:
6.9.1. Not reached the same level as specified in the approved outline before performing the study.
6.9.2. Proportion of adverse reactions (ADR) in the study drug significantly more than the control drug.
6.9.3. Dietary have significantly influence on the bioavailability of drugs with no explanation or solution to adjust.
II/ CASE WHICH ARE NOT PROVIDED AFTER HAVING SUBMITTED ADDITIONAL RECORDS.
1. Additional Profile after the initial examination of the data due to lack of a prescribed and permitted supplements, but additional documents belonging to one of the cases specified in Section I.
2. The dossier supplements have some information and data is excluded from the additional requirements, amendments but with the change from the original submitted documents without the written notes / explanations attached follow.
3. Additional profile in which information, data contradict with the initial filings but no convincing explanation.
4. Additional incomplete contents on request without explanation.
5. Add 2 times for an additional written notice unless the additional written notifications contain the additional requirements needed longer time to perform as:
Testing finished product quality standards.
- Supplement GMP / FSC / CPP or other legal papers.
- Additional data new stability studies required by the Drug Administration.
- Data bioequivalence studies, bioavailability or clinical records.