The B certificate application process is optimized, and the trustee GMP certificate is exempted!

The flow of approval documents between provinces has been ignited at the policy lev.

Since mid-May, four provinces of Anhui, Sichuan, Hebei and Shanxi have issued relevant policies that are conducive to the inflow of drug approva.

On May 12, the "Several Measures of Anhui Provincial Drug Administration on Implementing "One Change and Two Actions" to Continuously Optimize Administrative Examination and Approval (Draft for Comments)" was released to optimize the change of drug marketing authorization holders or the registration of existing varieties under developme.

On May 30, Sichuan issued "Several Measures on Further Promoting the Innovative Development of the Pharmaceutical Industry (Trial) (Draft for Comment)" to simplify the process of GMP compliance inspecti.

On May 31, Hebei issued the "Several Measures on Further Supporting the High-Quality Development of the Pharmaceutical Industry", becoming the first province to officially optimize the process of changing drug marketing authorization holders or the registration process of drug products under developme.

From June 10th, the "Several Measures to Fully Promote the Multiplication of Market Entities and Promote the High-Quality Development of the Pharmaceutical Industry" issued by Shanxi has been officially implemented, and the "Drug Production License" (B and C) can be approved with conditio.

B certificate application process optimization

B certificate, that is, the type of production license that needs to be obtained when the drug marketing authorization holder entrusts others to produ.

Hebei stipulates that "enterprises applying for a Class B drug production license for the change of domestic holders or the registration of research-in-development products may be exempted from submitting an opinion on consignment production issued by the provincial drug regulatory authority where the trustee is locat.

Anhui, on the other hand, mentioned in "Attracting high-quality Chinese medicine varieties from other provinces to gather in Anhui", for enterprises in Anhui Province that intend to acquire Chinese medicine varieties already on the market in other provinces, they are exempted from submitting the consent issued by the provincial bureau where the transferor is located when applying for the production license of Class B dru.

Shanxi B-certificate and C-certificate (C-certificate represents an enterprise that accepts the entrustment of the owner of the drug approval document or the holder of the drug marketing authorization to produce the drug of this type) can adopt the method of conditional approval during drug registration, which also relatively simplifies the proce.

In contrast, Hebei is applicable to a wider range and is more convenient, including the change of domestic holders and the registration of under-research varieties; Anhui only involves marketed Chinese medicine varieties and under-research varieti.

With the release of Hebei and Anhui policies, it is expected that each province will issue targeted policies according to their own needs in the near futu.

At present, the precondition for the change of the listing license holder is the B certificate of the province to be transferr.

Hebei plans to no longer require the entrusted provincial bureau to issue new regulations that agree with the entrusted opinion, which greatly reduces the workload of B-certificate processi.

It is expected that in the future, the provincial drug administrations will pay more attention to the management of marketing license holders, especially the on-site verification of the B license syst.

Exemption from submitting trustee GMP certificate

Another advantage is that the trustee's GMP compliance inspection certification data is exempted from submission in various process.

Hebei stipulates that for varieties whose domestic holders have changed or are registered under research, if the entrusted party has obtained the production scope of the transferred varieties or the corresponding dosage forms of the under research, it is exempt from submitting the certification materials for passing the drug GMP compliance inspecti.

Anhui mentioned in "Supporting the Development of R&D Drug Marketing Authorization Holders" that for enterprises that intend to apply for a Class B drug production license through the transfer of drug approval numbers, if the transfer party's drug production license already has the transferred varieties The production scope of the corresponding dosage form is exempt from submitting the certification materials for passing the GMP compliance inspection; for non-first-time applications, a written inspection can be implemented based on the risk principle, and on-site inspection is exempt.

As mentioned in "Transfer of high-quality Chinese medicine varieties", if the production license of the transferring party already has the production scope of the corresponding dosage form of the transferred variety, it is exempted from submitting the certification materials for passing the GMP compliance inspecti.

Sichuan stipulates that the defect rectification report of the GMP compliance inspection shall be directly reviewed by the technical review agency, and the on-site review shall be organized based on the risk assessme.

The entrusted inspection items that meet the scope and conditions of the entrusted inspection are optimized from pre-reporting to post-event reporti.

The regulations of Anhui and Hebei are conducive to attracting the transfer of product approval documents that no longer have product lines but whose production scope is retained to their own provinc.

Activate a "dormant" product

In addition, some new regulations will facilitate the resumption of production of a batch of "dormant" products that have not been produced for a long ti.

For chemical drugs that have not been produced for a long time after the drug is approved for marketing and other reasons, the quality comparison study before and after the change of production site cannot be carried o.

Hebei stipulates that the holder can choose the original research product and the generic drug reference preparation as the control to carry out the quality comparison stu.

Anhui also has similar regulations, but the reference products are different, and the original research products or varieties that have passed the consistency evaluation are select.

This is good for chemical products with reference preparations, including original products or varieties that have passed the consistency evaluati.

Resumption of production of chemicals without reference preparations is expected to be difficu.

If it is really impossible to carry out comparative research on the exclusive varieties of traditional Chinese medicine or exclusive production varieties, and there is no potential safety hazard after risk assessment, both Hebei and Anhui are exempted from submitting quality comparison research materials before and after the chan.

This is good for exclusive Chinese medicine products that have no risk (especially non-toxic medicinal materials) that have not been produced for a long ti.

Approvals for such products are expected to doub.

Shanxi and Sichuan have no relevant policies y.

And provinces that want to activate exclusive dormant TCM products are expected to issue similar regulatio.

Thinking questions<<<

Strict inspection of MAH changes to improve efficiency

The optimization of the B certificate application process means that the change of the marketing authorization holder of a product can be completed in about 3 mont.

Does this mean that the provincial bureau "releases water" on the transfer of approval documents? of course not!

In fact, for the management of approval documents, the provincial bureau has focused on whether the new marketing authorization holder can perform its duties after the change of the marketing authorization hold.

Be aware of re-registration issues

For the re-registration of "dormant" products that have not been produced for a long time, Anhui has new requirements: if a drug that has not been produced for five years applies for re-registration, if the dosage form of the drug does not conform to the production scope of the company's "Drug Production License" or the entrustment has not yet been determined Manufacturers, holders should provide plans to increase the scope of production or clarify the entrusted manufacturers, and promise to complete the registration before the next drug re-registrati.

Those who meet the conditions will be re-registered, and the work content and time limit that should be continued to be completed will be stated in the drug re-registration approval noti.

If the drug production site is changed before the resumption of production of the drug product re-registration approval document that is stated as "long-term non-production", if the change study cannot be completed at the new production site due to objective reasons such as the overall relocation of the enterprise, the holder shall When submitting an application for changing the drug production site to the provincial bureau, the submission of research materials for change can be exempted; however, before submitting an application for resumption of production, the holder should complete the change research, evaluation and necessary verification work in accordance with the requirements of the relevant technical guidelines for change, and comply with the re-registration approv.

Relevant requirements, and submit change research materials, the provincial bureau will carry out on-site inspection and technical review togeth.

If major changes are involved, it shall be reported to the Center for Drug Evaluation of the State Food and Drug Administration for approv.

This means that if production is not resumed after five years, Anhui's "dormant" product approval may be invalidat.

In addition, no matter how many hands are transferred, the research required for re-registration must be completed before production can be resumed, which increases the difficulty of resuming production and may affect those approval documents that have been unable to resume production due to various difficult proble.

In addition, on the issue that “application for consigned production of drugs (increase of production address) involving the re-registration of drugs as long-term unproduced varieties can be carried out simultaneously” that has troubled provinces before, Anhui (draft for comments), Shanxi and Hebei basically clarified the holder or the A drug manufacturer may simultaneously submit an application for entrusted production of drugs and an application for resumption of production, and conduct on-site inspection, registration inspection, and on-site inspection of entrusted production togeth.

Strict GMP inspection after transfer

It is worth noting that the holder may face strict GMP compliance checks after the chan.

Hebei requires that, for the varieties whose domestic holders have changed or are registered under research, after obtaining the holder's change approval document or drug registration certificate, the holder and its entrusted production enterprises have passed the drug GMP compliance inspection and the products meet the release requiremen.

Available for sa.

For new drugs that have not yet obtained drug approval numbers and drugs that have passed the consistency evaluation of generic drugs, priority should be given to drug GMP compliance inspections, which need to be combined with on-site registration verificati.

For generic drugs that have obtained a drug approval number, and drugs that have completed the change of drug marketing authorization holders and the variety production line has not undergone substantial changes, the production line of which has passed the drug GMP compliance inspection within one year and is in normal production stat.

, according to the law and based on the principle of risk management, after a comprehensive assessment, the production site inspection can be exempted, except for high-risk varieties, special complex dosage forms, and varieties explicitly required by national polici.

Anhui requires that the drug transferred by the holder of the R&D drug marketing authorization must pass the GMP compliance inspection after the change and the entrusted production enterprise, and only after meeting the release requirements can it be produced and marketed; in terms of the introduction of high-quality traditional Chinese medicine varieties from other provinces, After Anhui enterprises are approved as holders of drug varieties, priority will be given to GMP compliance inspectio.

For the subsequent transfer of varieties to Anhui Province for production, on-site inspections of drug production licenses, registration verifications and GMP compliance inspections will be implemented in parallel (merge.

To sum up, the GMP compliance inspection after the approval of the change of the marketing authorization holder is expected to be very stri.

High-risk varieties, special and complex dosage forms, and varieties clearly required by national policies (ie, registration applications for narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, pharmaceutical precursor chemicals, e.

with other special management regulations) are expected to be They do not enjoy preferential policy treatment, but are the target of strict monitori.

Outlook

It is expected that the simplified drug transfer and commissioned production process in each province will be released in successi.

Provinces use policies to attract products to the market, and the battle for approval is expected to start within two yea.

The next step depends on the tax policy implemented by MAH and the purchasing power of approval documents of local enterpris.

For the approval of the transfer, the provincial bureau GMP compliance inspection is stri.

This is a threshold for marketing authorization holders who have no production base (especially R&D) before, and approvals that do not resume production due to various problems will be challeng.