- Once request for proposal is submitted, how soon we can hear back from you?
- What preliminary information will be provided to us after the first inquiry with PHDS?
- Who do the translation of the application material?
- How can the quality of application material be assured?
- If a product has been marketed outside China for long time, does it mean an easier regulatory approval by China Agent?
- Once the cooperation with PHDS begins, how and when we will be updated on the project progress status?
- The distinguish between prescription and OTC?
- Comparatively, which one has better curative effects, RX or OTC?
- Is prescription medicine allowed to advertise on mass communication media?
- Why is it said that the classification of RX and OTC is an international drug management module?
- Is it correct that ¡°there is no problem for increasing dosage of OTC as it is safe¡±?
- What if dissent arises to the result of drug control?
- What is the system and measurement adopted to Adverse Drug Reaction in China?
- What is new drug post-marketing surveillance?
- Whom should I report to if there are suspiciously adverse effects?
1. Once request for proposal is submitted, how soon we can hear back from you?
Our customer care department works closely with our project team and contract service group. No matter the lead source is from web, telephone, fax, or email, getting back to all your questions and concerns within 24 hours is the bottom line our practice is based upon.
2. What preliminary information will be provided after the first inquiry with PHDS?
Generally, based on your inquiry, we will do a thorough evaluation of your product / project. Based on our experience, a good analysis with considerations on the potential risk, resources needed, timeline, procedures, and quotation with cost break-down details will be shared with you.
3. Who do the translation of the application material?
Professional material translation and audit are taken care of by PHDS project teams. We didn¡¯t contract the translation out to the third party. First, we want to secure the confidentiality of all your product information, and our registration information as well. Second, we keep the highest professional level of the to-be-submitted material. Our translators with majors in Pharmacy, Formulation, Biology, Biochemistry and years of experience of working with oversea pharmaceutical or health organizations. They not only know the technical terms but understand the technical implications. Meanwhile, any discrepancies or translation error might lead to significant differences on technical data. Third, during translation practice, communication between you and PHDS can also help attain an error free material preparation in a very efficient way.
4. How can the quality of application material be assured?
We give the application material a double-secure system to ensure its quality and acceptability by China Agency. Once the application material is finished by project team, the whole set of material, as our internal normal practice, is always assigned to the second party, our inspection group, for ¡°second pair of eyes¡± examination and validation. Any inconsistencies, errors will be sifted through during this procedure. Beyond that, before submitting the application material to the Agency, we also organize PHDS¡¯ expert panel meeting to double check the document. With the aid of our exclusive experts¡¯ long-time industry and regulatory compliance experiences, we render the material full-scope qualifications
5. If a product has been marketed outside China for long time, does it mean an easier regulatory approval by China Agent?
Not really. Although, being compatible with ICH guideline, China regulatory policies sometimes set narrower limits for the technical requirements. That is the reason that why many of our clients (manufacturers or distributors) initially believed their popular products can get approval in China easily, but ended up with coming to us for ¡°secret weapons¡± to help rescue their products that had been stuck in dilemma for months or even years.
Our people with piles of successful cases behind each of them, and with good skills of communicating with local agency or authorities, are able to predict the potential risks even before the project starts. As risks are identified so early, problems can always be circumvented in a creative and smart way.
6. Once the cooperation with PHDS begins, how and when we will be updated on the project progress status?
PHDS pays big attention on communication with our clients. On a regular basis, we generate progress report and share with our clients for updates. In the meanwhile, a very active information exchanges are taken place between the focal contact persons of each side. Telephone conferences can also be called up whenever necessary. We always believe the spirit of cooperation and the convenience of communication can make impossible possible. While providing you our best professional service, we are never satisfied until you are.
7. The distinguish between prescription and OTC?
In China, there are over ten thousands of botanical or chemical drugs in the market, some of which consumers legally have access without a prescription, by over-the-counter purchase is approved a switch by State Food and Drug Administration (SFDA), P.R. China. On the ground of the principal of safety assurance, definite efficacy, assured quality and convenient to use, the list of ingredients that have made the switch from Rx to OTC is generated and published by SFDA from the drugs available in domestic market.
When apply the registration with SFDA, the proposed import drug, if is approved a switch overseas, is eligible to apply for OTC immediately.
8. Comparatively, which one has better curative effects, RX or OTC?
When an ingredient is first introduced as an OTC medicine, it typically has been marketed as a prescription first. Then, after a sufficient amount of time has passed to enable to gather appropriate scientific information on the product, it may elect to submit a new drug application to SFDA so that it may be considered for OTC status. FDA experts review the application and determine if that product has a high enough safety profile and if labeling can be developed so that the medicine can be marketed safely and effectively as an OTC medicine.
A high enough safety profile, however, is not easy to reach. Those with approved effective would still not be considered if it either lacks of approved safety assurance, or inconvenience to use. Typically, it would take the new indigenous RX 3-5 years to be qualified to apply for switching to OTC.
9. Is prescription medicine allowed to advertise on mass communication media?
It is allowable for prescription medicine to introduce them on medical science, pharmacy science specialty publication jointly specified by the Minister of Health and State Food and Drug Administration, but is prohibited to advertise on mass communication media or any other media to public.
10. Why is it said that the classification of RX and OTC is an international drug management module?
Medicine is such an exceptional commodity that includes a variety of health care practices evolved to maintain and restore health by the prevention and treatment of illness.
Until the 1960s, in the hope of improving safety and control on the sales of virulent and habit-forming substance, most of drugs of abuse were designated as prescription-only medicines under the laws or regulations promulgated by the regulatory agencies in each country. Presently every country has realized the importance of the medication classification management for safety and effective use of medicine. WHO has advised the developing countries to implement this management system, even, in1989 suggested every country to involve it in the provision of their medicinal regulations or laws.
11. Is it correct that ¡°there is no problem for increasing dosage of OTC as it is safe¡±?
No, absolutely wrong. In term of safety for OTC, it is strictly restricted within the direction of specification. People simply take usually safe medicines in increasing amounts every day, those drugs build up in their systems causing the risk of injury or death. The abuse of over the counter medications is a growing problem, with intentional and accidental overdoses increasing every year. for instance, Vitamin C is an essential nutrient for humans and certain other animal species, in which it functions as a vitamin, and hence regard as safety. On the ground of historical researches, Dietary Reference Intake (DRI) recommend a daily dietary reference amount of Vitamin C, a continuing overdose of which may cause some untoward effects such as Abdominal pain, Diarrhoea, even urate and/or oxalate stones.
12. What if dissent arises to the result of drug control?
If dissent arises to the result of drug control, it is entitle to launch a review system with the original drug control organisation or a higher level organisation, even with the drug control organisations that directly subordinate to SFDA, within 7 days after the result being received. The drug control organisation who is undertaking review process must make a conclusion within the time regulated by SFDA.
13. What is the system and measurement adopted to Adverse Drug Reaction in China?
China's National Center for Adverse Drug Reaction (ADR) Monitoring was established in 1989. In 1998, nearly a decade later, China joined the World Health Organization's (WHO) Programme for International Drug Monitoring. During March 2004, China formally promulgated the final version of the Regulations on Adverse Drug Reaction Reporting and Monitoring.
Procedurally, the formal Chinese monitoring system requires pharmaceutical industry and healthcare professionals to report most ADR events quarterly. However, new, uncommon, serious or `group' ADRs are required to be reported within a shorter time period. Reports will be made to local centres, which then analyse and transmit them to a national ADR centre operated by China's State Food and Drug Administration (SFDA). The national authority is then empowered to authorise further studies within 5 days, and publish formal warning announcements or prohibit use of a product within 15 days.
14. What is new drug post-marketing surveillance?
A medicine, once been authorised and placed on the market, must be monitored by Adverse Drug Reaction Monitoring Centre through its entire life cycle, as part of the entire monitoring system.
The Regulations on Adverse Drug Reaction Reporting and Monitoring requires healthcare professionals, pharmaceutical manufactories and other independent specialty orgnisations, in a number of different ways, monitor and study on the medicine, then report any ADR Event to SFDA, eg. IV clinical trial, epidimeci disease research, Prescription Event Monitoring.
15. Whom should I report to if there are suspiciously adverse effects?
When suspiciously adverse reaction occurred, it is required to report to particular local centre for Adverse Drug Reaction Monitoring; or directly report to national centre for Adverse Drug Reaction Monitoring, if no local Centre for Adverse Drug Reaction Monitoring was established.
For any other concerns or question, please don¡¯t hesitate to contact our customer care department at customer@cnphds.com or dial 86-10-84466227/28/29.
