The pharmaceutical industry—the next round of elimination has begun!

The first China Pharmaceutical Regulatory Science Conference 2016, hosted by the China Association for Drug Regulatory Research, was held in Beijing. At the conference, Cyble learned that work has already begun on drafting the 2020 edition of the Chinese Pharmacopoeia.  
According to Zhang Wei, Secretary-General of the National Pharmacopoeia Committee, who spoke at the meeting, the 2020 edition of the Chinese Pharmacopoeia is planned to include up to 6,400 entries. This represents an increase of 800 entries compared to the 5,608 entries included in the 2015 edition. The focus is on adding more standards for raw materials, traditional Chinese medicinal materials, and pharmaceutical excipients.  
Among these, the number of traditional Chinese medicine varieties is proposed to increase by 220, the number of chemical medicine varieties is proposed to increase by 420, the number of biological products is proposed to increase by 30, the number of pharmaceutical excipients is proposed to increase by 100, and the number of pharmaceutical packaging material varieties is proposed to increase by 30.  
The 2020 edition of the Pharmacopoeia proposes to revise the standards for 1,400 varieties, including 500 traditional Chinese medicines, 600 chemical drugs, 150 biological products, and 150 pharmaceutical excipients.  
Shi Zhijiang, a well-known industry expert, told Cyberspace Blue that each revision of the Pharmacopoeia represents an upgrade in standards. Once the standards are raised, companies failing to meet these new requirements will be eliminated. In other words, every revision of the Pharmacopoeia is essentially a survival-of-the-fittest process. For instance, the 2015 edition of the Pharmacopoeia saw as many as 43 varieties removed from the list compared to the 2010 edition.  
Standards for Chinese medicinal herb slices will be further enhanced.  
On December 1 last year, the 2015 edition of the Pharmacopoeia came into effect. A major feature of the new edition is the substantial enhancement of standards for prepared medicinal materials.  
The standards for traditional Chinese medicine herbal slices have been significantly raised, particularly in terms of safety indicators. New limits have been introduced for sulfur dioxide residues in both Chinese medicinal materials and herbal slices, and stricter standards have been set for pesticide residues, heavy metals, and aflatoxins. The effective implementation of these enhanced standards hinges on the standardization of the entire Chinese medicine industry chain—especially the regulation of Chinese medicinal material cultivation and trade. Just the introduction of these new standards has already prompted many Chinese medicine enterprises to report a substantial increase in costs. In the Chinese medicinal material market, after the standards were raised, some traders reported a surge in returns.  
Relevant authorities stated that the 2020 edition of the Pharmacopoeia will further strengthen the development of standards for the safety of Chinese medicinal materials. It is planned to refer to the methods used in food safety assessments, and based on large-scale surveys of contaminants in Chinese medicinal materials as well as scientific research and big data, work will be initiated to establish maximum residue limits for pesticides and heavy metals in certain varieties.  
This means that the standards for Chinese medicinal materials will be further raised in the future.  
A manager at a traditional Chinese medicine enterprise sighed, “If TCM companies don’t start building their own medicinal herb bases soon, they’ll be out of the game. If they continue producing and purchasing herbs under the current model, given how stringent drug regulatory inspections have become—especially with the recent warnings issued to pharmaceutical companies urging all enterprises to pay close attention to drug raw materials—it’ll truly be too late if they wait until 2020, when standards are set to rise.”  
Chinese medicine injections are a key focus of attention.  
The 2020 edition of the Pharmacopoeia is proposed to add 800 varieties, including 220 additional traditional Chinese medicine (TCM) varieties. Although the number of added TCM varieties is fewer than that of chemical drug varieties, given that the total number of TCM formulations is already smaller than that of chemical drugs, this growth rate deserves close attention. For TCM enterprises, this also marks a new round of standard-setting and upgrading.  
In the field of traditional Chinese medicine, safety research is a key focus of particular concern. According to relevant sources, the Pharmacopoeia will place special emphasis on establishing control methods and setting control limits for allergenic and allergy-like substances in Chinese medicinal injections.  
Recently, Peking Union Medical College Hospital released the first-ever study on the causes of anaphylactic shock in China, revealing that medications are a major trigger for anaphylactic shock among Chinese individuals, accounting for 7%. Among drug-induced allergic reactions, traditional Chinese medicine injections rank first, making up 37% of cases. The most commonly implicated injections are Qingkai Ling Injection, Shuanghuanglian Injection, and Houttuynia Cordata Injection. Antibiotics come in second, accounting for 24%, with penicillin being the primary culprit. Nonsteroidal anti-inflammatory drugs (NSAIDs), used for fever and pain relief, rank third, accounting for 16%.  
This actually provides a direction for safety research on Chinese medicine injections. If companies can take the lead in achieving breakthroughs in this area, we believe their research findings will be among the first to be incorporated into the Pharmacopoeia.  
Innovative drugs receive support.  
In this revision of the Pharmacopoeia, support for innovative drugs is also a key component, with new formulations being promptly included to fully reflect the achievements of pharmaceutical innovation.  
This is great news for companies dedicated to pharmaceutical innovation. The country’s expanded inclusion of innovative drugs means that you’ll become the pharmacopoeial standard for this product category.  
As for chemical drugs, developing innovative medicines can involve substantial investment. The Chinese Medicine Law, currently under revision, allows manufacturers of compound Chinese medicine preparations derived from time-honored classic prescriptions that meet specified criteria to submit only non-clinical safety study data when applying for drug approval numbers. Although many classic prescriptions already have existing products, what if some haven't been developed yet? Especially for certain ethnic medicines, this could indeed be an excellent opportunity.  
How should enterprises adapt to the new edition of the Pharmacopoeia?  
What principles did the 2020 edition of the Pharmacopoeia adhere to in its development, and how can enterprises adapt more effectively to these changes? According to Zhang Wei, the main principles of the 2020 edition of the Pharmacopoeia include:  
First, we must enhance drug quality and uphold the scientific rigor, advanced nature, practicality, and standardization of drug standards.  
Second, we will encourage technological innovation to ensure that more scientific research findings are translated into and applied in pharmaceutical standards.  
Third, we will adhere to the principle of survival of the fittest, with both an increase and a decrease in the varieties included. We will optimize new additions and reduce existing stock.  
Fourth, we will improve the standard-setting mechanism, emphasizing government leadership and enterprise as the main body.  
Fifth, there is interaction among drug standard formulation and consistency evaluation, case-based evaluation of traditional Chinese medicine injections, quality-based sampling inspections of drugs, and adverse drug reactions.