Contents
1. Regulatory, Pricing, and Reimbursement Overview
- What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country?
- What is the regulatory framework for the authorization, pricing, and reimbursement of drugs, biologicals, and medical devices?
- What are the steps to obtain authorization to develop, test, and market a product?
- What are the approximate fees for each authorization?
- For how long are marketing authorizations/registrations valid? How are marketing authorizations/registrations renewed?
- How does the authorization process differ between brand-name products and generic products? Are there differences for local manufacturers versus foreign-owned manufacturers?
- How are combination products (drug + drug, drug + biologic, drug + device, biologic + device, drug + biologic + device) regulated?
- How is compliance with regulation monitored and evaluated? Is the regulatory regime comparable with the U.S. Food and Drug Administration or the European Medicines Agency expectations and requirements?
- What is the potential range of penalties for noncompliance?
- Is there a national healthcare system? If so, how is it administered and funded?
- How does the government (or public) healthcare system function with private sector healthcare?
- Are prices of drugs and devices regulated and, if so, how?
- How are drugs and devices used by patients paid for? What roles do public and private payers play?
- Who dispenses drugs and devices to patients and how are those dispensers compensated?
- What are the professional and legal responsibilities of those who dispense drugs and devices? What role do they play in providing patient care, information, and safety?
2. Preclinical & Clinical Trial Requirements
- Outline the progression from drug/device discovery to preclinical trials to clinical trials to marketing approval.
- What authorizations are required for each stage in research, development, and testing?
- Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval?
- How are clinical trials funded?
- What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?
- What are the requirements for consent by participants in clinical trials?
- May participants in clinical trials be compensated?
- How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?
3. Marketing, Manufacturing, Packaging & Labeling, Advertising
- What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products?
- What is the authorization process for the marketing of generic versions of these products?
- What are the typical fees for marketing approval?
- What is the period of authorization and the renewal process?
- What are the requirements, if any, for post-approval pharmacovigilance?
- Are foreign marketing authorizations recognized?
- Are parallel imports of medicines or devices allowed?
- What are the restrictions on marketing practices such as gifts, sponsorships, consultancy agreements, travel and entertainment, or other incentives for healthcare organizations and individual medical practitioners?
- How is the manufacturing of medicines and devices regulated and by which agencies?
- Are local manufacturing requirements compatible with Good Manufacturing Practices (GMPs) as defined by the U.S. Food & Drug Administration and/or the European Medicines Agency?
- What is the inspection regime for manufacturing facilities?
- Are manufacturing facilities open for inspection by foreign inspectors or third-party inspectors as authorized by the FDA/EMA?
- What are the requirements for storage, packaging, and handling of medicines and devices and their constituent components?
- What information must be included in medicine and device labeling?
- What additional information may be included in labeling and packaging?
- What items may not be included in labeling and packaging?
- What are the restrictions and requirements for the marketing and advertising of medicines and devices?
- Where can medicines and devices be sold or delivered? Can medicines and devices be sold or delivered via post?
- What are the restrictions and requirements for electronic marketing and advertising via email, by Internet, social media, and other channels?
- May medicines and devices be advertised or sold directly to consumers?
- How is compliance monitored?
- What are the potential penalties for noncompliance?
4. Traditional Medicines and Over-the-Counter Products
- What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?
- Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?
- What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?
- What are the regulatory requirements for over-the-counter (non-prescription) medications?
- Are there any limitations on locations or channels through which OTC products may be sold?
- What health, advertising, and marketing claims may be made for OTC products?
- Can OTC products be marketed or advertised directly to the public?
- What is the mechanism by which a prescription-only product can be converted to an OTC product?
- What are the requirements for the importation of either traditional medicines or OTC products?
5. Product Liability
- What types of liability are recognized in your jurisdiction?
- How do these types of liabilities apply to the manufacturers of medicines and devices?
- Does potential liability extend to the manufacturer only or could claims extend to corporate executives, employees, and representatives?
- How can a liability claim be brought?
- What defenses are available?
6. Patents and Trademarks
- What are the basic requirements to obtain patent and trademark protection?
- What agencies or bodies regulate patents and trademarks?
- What products, substances, and processes can be protected by patents or trademarks and what types cannot be protected?
- How can patents and trademarks be revoked?
- Are foreign patents and trademarks recognized and under what circumstances?
- Are there any non-patent/trademark barriers to competition to protect medicines or devices?
- Are there restrictions on the types of medicines or devices that can be granted patent and trademark protection?
- Must a patent or trademark license agreement with a foreign licensor be approved or accepted by any government or regulatory body?
7. Regulatory Reforms
- Are there proposals for reform or significant change to the healthcare system?
- When are they likely to come into force?
8. Cannabinoid Drugs, Medicinal Cannabis & Opiod Drugs
- Are Cannabinoid Drugs authorized in your country?
- What are the regulatory authorities with jurisdiction over Cannabinoid Drugs?
- Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Cannabinoid Drugs?
- Which are the cannabinoid drugs that have received market approval to date?
- Who can prescribe Cannabinoid Drugs?
- Is there a list of doctors authorized to prescribe Cannabinoid Drugs?
- What approvals or notifications are required to prescribe Cannabinoid Drugs?
- Which organizations are authorized to sell/distribute Cannabinoid Drugs available?
- Is there a list of retailers/distributors authorized to sell Cannabinoid Drugs?
- Are there proposals for reform or significant change to the regulation of Cannabinoid Drugs?
- When are they likely to come into force?
- Is Medicinal Cannabis authorized in the country?
- What are the regulatory authorities with jurisdiction over Medicinal Cannabis?
- What is the regulatory framework for the authorization, pricing, and reimbursement of Medicinal Cannabis?
- How is the production and import of Medicinal Cannabis regulated and by which agencies/authorities?
- What approval or notifications are necessary to produce or import Medicinal Cannabis?
- What is the regulatory framework for the marketing and distribution of Medicinal Cannabis?
- How can patients obtain Medicinal Cannabis?
- Who can prescribe Medicinal Cannabis?
- Is there a list of doctors authorized to prescribe Medicinal Cannabis?
- What approvals or notifications are required to prescribe Medicinal Cannabis?
- Are Opioid Drugs authorized in your country?
- What are the regulatory authorities with jurisdiction over Opioid Drugs?
- Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Opioid Drugs?
- Which are the Opioid drugs that have received market approval to date?
- Who can prescribe Opioid Drugs?
- Is there a list of doctors authorized to prescribe Opioid Drugs?
- What approvals or notifications are required to prescribe Opioid Drugs?
- Which organizations are authorized to sell/distribute Opioid Drugs available?
- Is there a list of retailers/ distributors authorized to sell Opioid Drugs?
- Are there proposals for reform or significant change to the regulation of Opioid Drugs?
- When are they likely to come into force?
9. Orphan Drugs & Rare Diseases
- What is the definition of rare diseases in your country?
- Does the designation of 'orphan drug' exist in your country? (Does it correspond with the definition of rare diseases?)
- What is the regulatory framework for the authorization of an orphan drug? (Is this regulatory framework based on rare disease status or can it alternatively be based on orphan drug foreign status?)
- Does your country have provision for relaxed clinical trial/scientific evidence requirements in respect of orphan drugs as compared to other drugs?
- Is there an expedited pathway for orphan drugs?
- Are foreign marketing authorizations recognized in your jurisdiction for orphan drugs? if yes, marketing authorizations from which countries are recognized?
- Can orphan drugs be reimbursed? If so, is there a specific requirement procedure for orphan drugs?
- How are the prices of orphan drugs regulated?
- In case of reference price based on a basket of countries, what countries are included?
- Have there been any significant legal/judicial developments in relation to orphan drugs in your country?
- Are there proposals for reform or significant change to the regulation of orphan drugs? If yes, when are they likely to come into force?
10. Localization
- Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies?
- Have there been any recent significant changes involving localization rules? If yes, when did they take place and what did they involve?
- Is the process of obtaining a marketing authorization impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?
- Is the pricing process for pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?
- Is the reimbursement of pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?
- Are foreign marketing authorizations recognized in your jurisdiction for orphan drugs? if yes, marketing authorizations from which countries are recognized?
- Is the access to public or public tenders of pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?
- Are import tariffs, importation and/or exportation permits, trade and/or taxation of pharmaceutical products impacted by localization policies in your country? If yes, how so?
- Are there any other incentives or advantages offered by the current local localization rules in your country? If yes, what are they?
- Are there discussions about the possibility of implementing localization policies in your country? If yes, what are the proposed reforms and when should they come into place?
11. Biosimilars & Biologics
- Are biosimilar medicines considered the same as generic medicines in your country?
- Are all biologic medicines, including biosimilar medicines, patentable in your country?
- Is there a specific regulatory framework for the marketing authorization of biosimilar medicines in your country? If yes, what is the regulatory framework for the authorization of biosimilar medicines?
- What kind of data package is needed to obtain approval for a biosimilar drug? Is this any different to the requirements for the original Biologics drug?
- What are the requirements for the choice of the reference comparator product?
- Can the comparator product be sourced from another regulatory jurisdiction? If yes, what are the data needed to support this approach?
- How are the prices of biosimilar medicines regulated? Is this any different from the requirements for the original Biologics drug?
- What is the reimbursement policy for biosimilar medicine? Is this any different from the requirements for the original Biologic drug?
- Does biosimilar competition impact the reimbursement policy of the originator reference products?
- What is the legal framework for biosimilar medicines prescribing (clinical decision maker) and dispensing (pharmacy level, hospital or retail)? Is this any different to the requirements for the original Biologics drug?
- Is the system considering physician-led switching and/or pharmacy-level substitution (without involvement of the clinical decision maker)?
- What are the post-authorisation requirements (including pharmacovigilance, risk management plans, post-approval studies) for biosimilar medicines? Is this any different to the requirements for the original Biologics drug?
- Are there specific policies and requirements for labelling biosimilar medicines in the event of second medical use patents? Is this any different from the requirements for the original Biologic drug?
- Have there been any significant legal/judicial developments in relation to biosimilars in your country? (Including but not limited to IP, procurement, competition, misleading information campaign, access to reference comparator product)
- Are there proposals for reform or significant change to the legal, regulatory, procurement of biosimilars? If yes, when are they likely to come into force?
12. Medical Devices
- Who are the regulatory authorities governing medical devices in your jurisdiction?
- What is the regulatory framework governing the authorization, manufacture, import, pricing, sale, and advertisement of medical devices in your jurisdiction? Please provide a brief overview of the same.
- How are medical devices defined in your jurisdiction? Is software (whether standalone or part of a medical device) considered to be a medical device?
- What is the process for obtaining approval to market a medical device? Are approvals granted by foreign regulators recognized in your jurisdiction?
- What licenses/approvals are required to manufacture, import or sell medical devices? Can medical devices be sold directly to consumers?
- What are the standards required to be adhered to for manufacturers/importers of medical devices?
- What acts of non-compliance are specifically provided for under the regulatory framework? What is the range of penalties in case of such non-compliance?
- What are the remedies available to patients in case of harm/injury caused due to medical devices? What is the potential range of compensation/penalty in case of such harm/ injury?
- What information is required to be included on the label of the medical device?
- Are the prices of medical devices regulated and, if so, how?
- an medical devices be advertised directly to consumers? If not, what are the restrictions on marketing medical devices to consumers?
- How is the marketing of medical devices to healthcare practitioners regulated?
- Are there proposals for reform or significant change to medical device regulation? If yes, when are they likely to come into force?
13. Digital Health
- s the term ‘digital health’ defined in your jurisdiction? If no, how is the term generally understood?
- What digital health tools are specifically recognized and regulated in your jurisdictions?
- What is the regulatory framework applicable to the above-mentioned digital health tools? Who are the regulators with jurisdiction over these areas?
- How is health data regulated in your jurisdiction? Is there a separately regulatory framework governing health data?
- What are the obligations of entities collecting, storing, or otherwise processing health data in your jurisdiction?
- Can health data be transferred abroad in your jurisdiction? What restrictions (if any) are applicable to cross-border transfer of health data?
- Are there proposals for reform or significant change to digital health regulation? If yes, when are they likely to come into force?