The seventh batch of national procurement is connected to MAH, and the threshold for domestic agents is raised, which is beneficial to enterprises with their own production lines

The long-awaited seventh batch of national mining rules was finally announced on June 20, 202 On June 27, the interpretation of the key points of the seventh batch of national procurement was conducted in the form of an online meeti.

In terms of application qualifications, the seventh batch of centralized procurement requires domestic drug manufacturers, drug marketing authorization holders, and domestic agents of overseas drug marketing authorization holders that provide drugs and accompanying services, in terms of quality standards, production capacity, supply stability, Those who meet the requirements of this centralized procurement in terms of corporate credit and other aspects can participa.

Before the fifth batch of national procurement, centralized procurement did not require domestic agen.

The seventh batch of national procurement requires filling in the qualifications of domestic agents, which can only be filled in on the "Drug Annual Report Collection Modul.

The seventh national mining will start on July 12, 202 Domestic agents are required to have the legal representative of the enterprise, the person in charge of the enterprise, the person in charge of quality, the person in charge of production, the person in charge of quality authorization, and the person in charge of pharmacovigilance, which greatly improves the threshold for overseas generic drugs to enter the count.

The fifth batch of centralized procurement is only limited to "declaring different enterprises of the same species, if the person in charge of the enterprise is the same person or there is a direct holding or management relationship, the involved enterprises only have the lowest 'unit comparable price' and are not the last of the shortlisted enterprises to be shortlist.

The seventh batch of centralized procurement regulations, "the transfer of part of the valid registration approval documents", involves only the enterprise with the lowest "unit comparable price" and is not in the bottom of the shortlisted enterprises to be shortlist.

According to the rules, if company A entrusts company B to produce product M with national procurement qualification, and if company B and its group companies also have product M with national procurement qualification, then neither company A nor company B or company within the group can produce product.

First, although company A declares product M first, if its entrusted production contract does not sign an exclusive agreement with company B, and company B also declares product M (which company A cannot control), then company A will not be able to order the product at the highest pri.

Second, the cost of company A includes entrusted production + management cost of company A, which is higher than the overall cost of company B with production lin.

Third, further differentiate the future positioning of the entrusted production enterpris.

The meeting has always emphasized the risk control of related transactions between produc.

Whether it is an entrusted production enterprise or a listing license holder with a self-built production line, it is necessary to consider: even if the bid-winning rate of centralized procurement rises to about 80%, there is still a risk of not winning the bid; for the huge investment in production lines, what is the risk of idleness in the future ?

For some unique dosage forms, because it is not cost-effective to invest in new production lines, and if the invested production line does not win the bid, it will be idle and wasteful, so most companies (such as company A) prefer to entrust other companies to produ.

It was clarified at the meeting that during the period of the national procurement transaction, the holder of the listing license shall not be changed, the enterprise entrusted with the production shall not be changed, and the domestic agent shall not be chang.

If the national procurement clause affects the provincial procurement and becomes a major trend, then the existing outsourced production may face large-scale default even.

Outlook<<<

In view of the fact that the MAH system has not been implemented for a long time, it is expected that there are not many cases where the entrusting party and the entrusting party mentioned by Guocai have approval documents at the same ti.

The MAH system is a system that is in line with international rules to promote the internationalization of domestic companies; domestic R&D companies and marketing companies consider the MAH system to be a great opportunity for transformati.

On the other hand, Guocai pays more attention to cost control and supply stability, and the bidding rules prefer enterprises with their own production resources to participate in centralized procureme.

It is difficult for the method of entrusted production and multi-location production to have an advantage in the price war of domestic procurement, especially since the manufacturer is always its own competitor and controls its own cos.

The national procurement policy is more favorable for enterprises with fixed asse.

Companies that want to transform through the MAH system may need to think: Should they invest in fixed assets in the future? What kind of generic drug is suitable for development?

Related<<<

MAH system activates multiple dividends

With the release and implementation of the newly revised Drug Administration Law in 2019, the Marketing Authorization Holder (MAH) system was officially established in China in the form of l.

In 2020, the new "Measures for the Administration of Drug Registration" and the new "Measures for the Supervision and Administration of Drug Production" were successively promulgat.

The above regulations have laid the foundation for the separation of marketing authorization and production enterprises, the commissioned production of drugs and multi-site producti.

In 2022, provinces will gradually release the application requirements for B certificat.

The difficulty of transforming R&D CROs and marketing CSOs into MAHs without production conditions is decreasing, and they can transform only by complying with relevant quality syste.

The MAH system separates the listing authorization from the production enterprise, which brings long-term dividends to many parties:

① It is clear that R&D institutions can also become MAHs, which will greatly stimulate the enthusiasm for R&D and help incubate and release the productivity of drug R&.

②The primary responsible person for the entire life cycle of the drug has been established, which helps to promote the gradual realization of the main responsibility of MAH, and all relevant parties assume their corresponding responsibilities, thus contributing to the scientific supervision of the governme.

③ Greatly enhance the freedom of enterprises to allocate resources independent.

Enterprises can build their own production sites, entrust production, entrust operation, and transfer MAH, e.

; improve the management capabilities of enterprises, and lay the foundation for future mergers and acquisitions and management of foreign resourc.

④Optimizing the allocation of industry resources is conducive to improving industrial efficiency, promoting industrial upgrading, promoting enterprises to participate in cross-border exchanges and international competition, and conducting international mergers and acquisitions and international market development, so as to make enterprises bigger and strong.

To sum up, MAH can have its own production site or commission production, which is a big bonus of the MAH syst.

If my country's pharmaceutical industry is to be internationalized, it must be proficient in the MAH system in the future:

①Establish domestic and foreign R&D centers;

②Establish a single or multiple production sites at home and abroad to carry out staged production, or multiple production sites of the same process back up each other, or carry out entrusted production;

③ Expand product lines and production lines through overseas mergers and acquisitions;

④The production and development are overseas, and the domestic enterprises in China, as MAHs, are responsible for the marketing and sales of products in China and the management of the whole life cycle of drugs;

⑤ Domestic enterprises, as MAHs, are responsible for the marketing and sales of products outside China and the management of the whole life cycle of drugs (the location of production and research and development may be domestic or oversea.