Last year, the European Commission decided to conduct a long and comprehensive review of the EU pharmaceutical industry with an ever-growing territory. How will the EU pharmaceutical industry be regulated in the future?
With the European Commission gradually recognizing that globalization, the expansion of the EU's internal markets, and advances in science and technology are changing the pharmaceutical environment, major discussions around regulatory issues have also started. These issues will affect all stakeholders in the pharmaceutical industry.
Prior to this, the IPEC-Europe International (IPEC-Europe) held a seminar in Cannes, France. Participants evaluated the environment for the supervision of excipients in Europe and discussed the new issue of counterfeit products and other emerging challenges. .
Difficult counterfeit products Although in people's minds, the counterfeiting activities in the pharmaceutical industry are usually illegal imitations of manufactured drugs, but now, one of the more worrying ones may be that some counterfeit raw materials (including accessories Inside) may also have entered the supply chain.
Counterfeit accessories have apparently become an issue of unusual concern to the US Food and Drug Administration (FDA). Steven Wolfgang of the FDA's Center for Drug Evaluation and Research pointed out that cases that have occurred in recent years (such as replacing proteins with melamine and diglycerol instead of medicinal glycerine) suggest that commercialized raw materials (not necessarily expensive drugs) are becoming Some criminals quickly seek to make huge profits.
Last year, the FDA issued a guideline recommending that a special test for diethylene glycol content be added to the identification test of glycerol products. The FDA also now demands that once the merchant's glycerol raw material is handed down, it must be tested once.
Wolfgang confirmed that the integrity of the supply chain continues to be a hot topic in the United States. He specifically mentioned the "Inter-agency Working Group on Import Safety" set up by the U.S. government and an action plan announced in November last year that calls for risk management measures that focus on prevention. Interestingly, this action plan puts forward a number of recommendations, including the promotion of certification systems for foreign companies, the expansion of laboratory testing capabilities, and the increased use of electronic tracking and search systems, all of which may be Pressure on excipient manufacturers.
The World Health Organization (WHO) is also addressing the issue of counterfeit products through its “IMPACT†set up in late 2006. Dr. Sabine Kopp of WHO sent an invitation letter to IPEC-Europe and its sister organization IPEC-Americas and the Japan Pharmaceutical Excipients Association (JPEC) to invite them to participate in this action plan.
At the seminar held in Cannes, France, a document “Good Auditing Guidelines for Material Distribution Management†(GDP) was published. This document was prepared by the GDP Committee of IPEC-Europe. . The use of this document in conjunction with the IPECGDP Guide published in 2006 will assist in the auditing of companies in the excipient supply chain. IPEC-Europe is also collaborating with IPEC-Americas to develop principles for excerpt documentation as part of the guidelines for quality verification of excipients.
The GMP space for excipient production at the IPEC-Europe seminar also introduced a new "IPEC GMP Audit Guideline" jointly developed with IPEC-Americas and the "Pharma Quality Group" to be developed with it in 2006. The GMP guidelines form a supplement. The introduction of this document was particularly timely because GMP has become a major issue in Europe. The auxiliary material production industry has been watching the European Commission after many years of discussion, how it plans to implement GMP standards for excipient production.
In fact, there are no objections to the implementation of GMP standards for certain excipients in accordance with the current regulatory measures - the European Parliament has already voted in favor of this. The key question is: What kinds of excipients will be included? What kind of GMP standards do the excipients apply to? Professor Henkde Jong, who took the chair of the European Pharmacopoeia Commission last year, told participants that there were four policy options discussed on the desktop for these issues: first, through legislation, second, acceptance of guidelines, and third, risk management measures. It is through industry self-discipline.
Judging from the current signs, people do not support the adoption of legislation to restrict the production of excipients. According to the recommendations made by the Commission of Medicine of the European Commission on December 12, 2007, risk assessment measures seem to be more respected by people. However, Henkde Jong emphasized that what kind of practice is currently adopted depends on the chairman of the Council of Europe and Industry of the European Commission GFCnter Verheugen.
Although the news was encouraging for the suppliers and users of the accessories, Henkde Jong cautioned that it is necessary for the IPEC to monitor this process. If things do not advance as expected, it will respond.
The expansion of the main file system is on the agenda of IPEC-Europe. Another relatively pressing legislative issue is the establishment of a European master file system for accessories. Considering that the main file system is limited to non-biological drug substances, the urgency is obvious.
Kate Denton of Sweden's Novozymes Biopharma, who serves on the IPEC-Europe Regulatory Affairs Committee, said that because of this limitation, manufacturers lack the incentive to bring new excipients to market, and for those companies investing in the development of new excipients, they will also Faced with intellectual property issues.
Unlike in the United States and Japan, in Europe, developers cannot submit new excipient documents to regulatory agencies for reference by pharmaceutical companies wishing to use such excipients. Instead, the developer had to inform its customers of valid intellectual property information and must submit it together with the sales permit application. As a result, the protection of new excipients through patents has become empty talk.
For raw material medicines, this kind of protection procedure has been generally accepted by everyone. In accordance with this procedure, generic companies may refer to the main document in the sales application when purchasing raw materials for their products. The raw material drug manufacturer's process and production measures are still confidential. This approach also prevents repetitive work because it avoids double-evaluation and relieves management pressures for excipient suppliers, pharmaceutical companies, and regulators.
IPEC-Europe has already shown its position. It is lobbying the European Commission to include the main file system as an auxiliary material on its agenda. Encouraging signs are that this may happen because the European Commission has already signalled in its consultation paper "The Future of European Medicines" that it is necessary to evaluate the main filing system.
Watch REACH with caution
As a landmark new regulation promulgated by the European Union, REACH regulations (regarding chemical registration, evaluation, licensing, and restrictions) have caused widespread controversy and controversy over the past few years, and have led to major policy changes. In fact, this regulation puts the burden of proof (that is, the substance used in pharmaceutical products is safe) from falling into the hands of the manufacturer rather than the regulator.
Although the REACH regulation covers all chemical products with an annual production volume or import volume exceeding 1 ton, pharmaceutical products can be exempted as long as they comply with the EU's 2001 Directive 2001/83/EC. This regulation is binding.
However, one of the key elements of the regulation will make pharmaceutical companies unable to ignore it. Regulations require that any substances that are used for other purposes as well as pharmaceutical products must be pre-registered this year and fully registered between 2010 and 2018, and the latter will depend on their annual production tonnage in the European Union. Or tons imported into the EU.
Sylvie Thevenet of Dow Corning France stated to those who participated in the IPEC-Europe seminar that pre-registration must be completed before December 1, 2008, so that chemicals can remain on the market after that, if at that time they There is no registration, then these chemicals must be fully registered in December or they will be evacuated from the market.
Failure to pre-register or register may affect the continuity of raw material supply. Pharmaceutical companies should consider whether to pre-register chemical substances (if their suppliers do not plan to do so), ensure that suppliers from non-European regions understand REACH regulations, and provide them when suppliers request access information.
Coordination must also be made. Efforts were also made by Janeen Skutnik of Pfizer Global Production Inc., who had just been elected as Chairman of IPECAmericas, at the IPEC Europe conference. She highlighted the slow progress in coherence between the United States, Europe and the Japanese Pharmacopoeia. She boldly asked: Is it time to cover the entire process so that the monographs between Europe, the United States, and the Japanese Pharmacopoeia can be mutually recognized?
Skutnik stated that if the three parties reach the following consensus: the pharmacopoeias of the three places come from an effective process, and monographs in any pharmacopoeia can be quoted and adopted without additional data files, modifications or verifications, then this will maximize Reducing resources used by manufacturers and regulatory authorities to reduce non-value-added testing activities.
The repetitive tests carried out due to the lack of consistent coherence do not bring benefits to the patient. They both waste time and resources and create environmental problems: the large amount of solvents required for dual and multiple trials are discarded.
It is precisely because of the realization that there is still a long way to go to achieve this revolutionary goal of pharmacopoeia consistency. Skutnik pointed out that this process can be accelerated in a gradual manner, such as the formulation of the expected work plan, with the participation of the three Pharmacopoeia institutions. Herbal monographs and new chapters.
The seminar clearly shows that the EU's regulation of pharmaceutical excipients is undergoing constant changes. The meeting also revealed some optimistic atmosphere, that is, through the cooperation between the industry, regulatory authorities and other stakeholders, the operating environment of the accessories suppliers and users may still be improved.
With the European Commission gradually recognizing that globalization, the expansion of the EU's internal markets, and advances in science and technology are changing the pharmaceutical environment, major discussions around regulatory issues have also started. These issues will affect all stakeholders in the pharmaceutical industry.
Prior to this, the IPEC-Europe International (IPEC-Europe) held a seminar in Cannes, France. Participants evaluated the environment for the supervision of excipients in Europe and discussed the new issue of counterfeit products and other emerging challenges. .
Difficult counterfeit products Although in people's minds, the counterfeiting activities in the pharmaceutical industry are usually illegal imitations of manufactured drugs, but now, one of the more worrying ones may be that some counterfeit raw materials (including accessories Inside) may also have entered the supply chain.
Counterfeit accessories have apparently become an issue of unusual concern to the US Food and Drug Administration (FDA). Steven Wolfgang of the FDA's Center for Drug Evaluation and Research pointed out that cases that have occurred in recent years (such as replacing proteins with melamine and diglycerol instead of medicinal glycerine) suggest that commercialized raw materials (not necessarily expensive drugs) are becoming Some criminals quickly seek to make huge profits.
Last year, the FDA issued a guideline recommending that a special test for diethylene glycol content be added to the identification test of glycerol products. The FDA also now demands that once the merchant's glycerol raw material is handed down, it must be tested once.
Wolfgang confirmed that the integrity of the supply chain continues to be a hot topic in the United States. He specifically mentioned the "Inter-agency Working Group on Import Safety" set up by the U.S. government and an action plan announced in November last year that calls for risk management measures that focus on prevention. Interestingly, this action plan puts forward a number of recommendations, including the promotion of certification systems for foreign companies, the expansion of laboratory testing capabilities, and the increased use of electronic tracking and search systems, all of which may be Pressure on excipient manufacturers.
The World Health Organization (WHO) is also addressing the issue of counterfeit products through its “IMPACT†set up in late 2006. Dr. Sabine Kopp of WHO sent an invitation letter to IPEC-Europe and its sister organization IPEC-Americas and the Japan Pharmaceutical Excipients Association (JPEC) to invite them to participate in this action plan.
At the seminar held in Cannes, France, a document “Good Auditing Guidelines for Material Distribution Management†(GDP) was published. This document was prepared by the GDP Committee of IPEC-Europe. . The use of this document in conjunction with the IPECGDP Guide published in 2006 will assist in the auditing of companies in the excipient supply chain. IPEC-Europe is also collaborating with IPEC-Americas to develop principles for excerpt documentation as part of the guidelines for quality verification of excipients.
The GMP space for excipient production at the IPEC-Europe seminar also introduced a new "IPEC GMP Audit Guideline" jointly developed with IPEC-Americas and the "Pharma Quality Group" to be developed with it in 2006. The GMP guidelines form a supplement. The introduction of this document was particularly timely because GMP has become a major issue in Europe. The auxiliary material production industry has been watching the European Commission after many years of discussion, how it plans to implement GMP standards for excipient production.
In fact, there are no objections to the implementation of GMP standards for certain excipients in accordance with the current regulatory measures - the European Parliament has already voted in favor of this. The key question is: What kinds of excipients will be included? What kind of GMP standards do the excipients apply to? Professor Henkde Jong, who took the chair of the European Pharmacopoeia Commission last year, told participants that there were four policy options discussed on the desktop for these issues: first, through legislation, second, acceptance of guidelines, and third, risk management measures. It is through industry self-discipline.
Judging from the current signs, people do not support the adoption of legislation to restrict the production of excipients. According to the recommendations made by the Commission of Medicine of the European Commission on December 12, 2007, risk assessment measures seem to be more respected by people. However, Henkde Jong emphasized that what kind of practice is currently adopted depends on the chairman of the Council of Europe and Industry of the European Commission GFCnter Verheugen.
Although the news was encouraging for the suppliers and users of the accessories, Henkde Jong cautioned that it is necessary for the IPEC to monitor this process. If things do not advance as expected, it will respond.
The expansion of the main file system is on the agenda of IPEC-Europe. Another relatively pressing legislative issue is the establishment of a European master file system for accessories. Considering that the main file system is limited to non-biological drug substances, the urgency is obvious.
Kate Denton of Sweden's Novozymes Biopharma, who serves on the IPEC-Europe Regulatory Affairs Committee, said that because of this limitation, manufacturers lack the incentive to bring new excipients to market, and for those companies investing in the development of new excipients, they will also Faced with intellectual property issues.
Unlike in the United States and Japan, in Europe, developers cannot submit new excipient documents to regulatory agencies for reference by pharmaceutical companies wishing to use such excipients. Instead, the developer had to inform its customers of valid intellectual property information and must submit it together with the sales permit application. As a result, the protection of new excipients through patents has become empty talk.
For raw material medicines, this kind of protection procedure has been generally accepted by everyone. In accordance with this procedure, generic companies may refer to the main document in the sales application when purchasing raw materials for their products. The raw material drug manufacturer's process and production measures are still confidential. This approach also prevents repetitive work because it avoids double-evaluation and relieves management pressures for excipient suppliers, pharmaceutical companies, and regulators.
IPEC-Europe has already shown its position. It is lobbying the European Commission to include the main file system as an auxiliary material on its agenda. Encouraging signs are that this may happen because the European Commission has already signalled in its consultation paper "The Future of European Medicines" that it is necessary to evaluate the main filing system.
Watch REACH with caution
As a landmark new regulation promulgated by the European Union, REACH regulations (regarding chemical registration, evaluation, licensing, and restrictions) have caused widespread controversy and controversy over the past few years, and have led to major policy changes. In fact, this regulation puts the burden of proof (that is, the substance used in pharmaceutical products is safe) from falling into the hands of the manufacturer rather than the regulator.
Although the REACH regulation covers all chemical products with an annual production volume or import volume exceeding 1 ton, pharmaceutical products can be exempted as long as they comply with the EU's 2001 Directive 2001/83/EC. This regulation is binding.
However, one of the key elements of the regulation will make pharmaceutical companies unable to ignore it. Regulations require that any substances that are used for other purposes as well as pharmaceutical products must be pre-registered this year and fully registered between 2010 and 2018, and the latter will depend on their annual production tonnage in the European Union. Or tons imported into the EU.
Sylvie Thevenet of Dow Corning France stated to those who participated in the IPEC-Europe seminar that pre-registration must be completed before December 1, 2008, so that chemicals can remain on the market after that, if at that time they There is no registration, then these chemicals must be fully registered in December or they will be evacuated from the market.
Failure to pre-register or register may affect the continuity of raw material supply. Pharmaceutical companies should consider whether to pre-register chemical substances (if their suppliers do not plan to do so), ensure that suppliers from non-European regions understand REACH regulations, and provide them when suppliers request access information.
Coordination must also be made. Efforts were also made by Janeen Skutnik of Pfizer Global Production Inc., who had just been elected as Chairman of IPECAmericas, at the IPEC Europe conference. She highlighted the slow progress in coherence between the United States, Europe and the Japanese Pharmacopoeia. She boldly asked: Is it time to cover the entire process so that the monographs between Europe, the United States, and the Japanese Pharmacopoeia can be mutually recognized?
Skutnik stated that if the three parties reach the following consensus: the pharmacopoeias of the three places come from an effective process, and monographs in any pharmacopoeia can be quoted and adopted without additional data files, modifications or verifications, then this will maximize Reducing resources used by manufacturers and regulatory authorities to reduce non-value-added testing activities.
The repetitive tests carried out due to the lack of consistent coherence do not bring benefits to the patient. They both waste time and resources and create environmental problems: the large amount of solvents required for dual and multiple trials are discarded.
It is precisely because of the realization that there is still a long way to go to achieve this revolutionary goal of pharmacopoeia consistency. Skutnik pointed out that this process can be accelerated in a gradual manner, such as the formulation of the expected work plan, with the participation of the three Pharmacopoeia institutions. Herbal monographs and new chapters.
The seminar clearly shows that the EU's regulation of pharmaceutical excipients is undergoing constant changes. The meeting also revealed some optimistic atmosphere, that is, through the cooperation between the industry, regulatory authorities and other stakeholders, the operating environment of the accessories suppliers and users may still be improved.
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